As many of you know, the combination known as R-Squared has been on Lymphoma specialists' minds for a while. In those review articles and videos that I like to link to, they almost always mention the combination as something that they are excited about. The results of a phase III trial of the combination is being presented at ASCO.
R-Squared stands for Rituxan and Revlimid (also known as Lenalidomide).
The ASCO presentation is called "RELEVANCE: Phase III randomized study of lenalidomide plus rituximab (R2) versus chemotherapy plus rituximab, followed by rituximab maintenance, in patients with previously untreated follicular lymphoma."
Researchers are using the trial to do a direct comparison between two treatments. A total of 1030 were split into two groups. One group received the "standard of care" -- the kind of treatment most patients would receive if they were not in a trial -- immunochemotherapy + maintenance. In this case, that meant R-CHOP, R-CVP, or R-Bendamustine, followed by Rituxan Maintenance (every 8 weeks for about 2 years).
The other group got the R-Squared, followed by the same Rituxan Maintenance.
The results were very interesting -- the two treatments were very similar in their effectiveness, but with different side effects.
The primary endpoints (that is, the measurements the researchers would use to figure out of R-Squared was better) were Complete Response (how many patients had their cancer wiped out) at 120 weeks, and Progression Free Survival (how long it took for the cancer to come back, or get worse).
The CR for R-Squared was 48% to 55% (depending on who was measuring), with the Immunochemo CR was 53% to 58%. Very similar.
The PFS at 2 years for R-Squared was 84%/84%, while the Immunochemo was 87%/83%.
The PFS at 3 years for R-Squared was 77%/77%, while the Immunochemo was 78%/78%.
[There are two numbers for each because there are two groups looking at the results -- the researchers themselves, and then an independent group of experts. This makes sure that the researchers aren't overlooking something because that would give better results. It's a sign that the researchers are taking the results very seriously and want them to be fair.]
The Overall Survival for both groups at 3 years was 94%. [Only one set of numbers there -- you really don't need independent experts to check if someone is still alive.]
So while the effectiveness of the two treatments is virtually the same, the differences came in the safety -- they had different side effects.
Patients in the Immunochemo group had higher instances of neutropenia (low levels of a white blood cell that fights off infections) and of fevers associated with neutropenia. The Immunochemo patients also had a slightly higher incidence of developing secondary cancers (9%, versus 7% in the R-Squared group).
The R-Squared group had higher rates of cutaneous events -- skin problems.
A couple of comments, for what they're worth (coming from a patient and not a medical doctor or researcher).
First, I really like that the researchers stayed fairly neutral in all of this. They sum it all up in the conclusion as saying "R-Squared showed similar efficacy and a different safety profile to R-chemo." It would have been easy to hint that R-Squared was better here, or that it prevented a better alternative. The numbers don't say that, but lots of researchers kind of use language that would suggest it. (A report in Lymphoma News Today does that, saying the results suggest that R-Squared could replace chemo.)
I am certainly prone to being (maybe overly) optimistic. For me, as a patient, that puppy-dog-like enthusiasm comes off as charming. But for the researchers, neutral is better. So I really appreciate that they are presenting data and letting others make the judgements about what it all means.
Second, my guess is that others will indeed give a positive spin to the results. The abstract states that "superiority for R-Squared over R-chemo was not established for both co-primary endpoints." That's a technical term for the clinical trial -- the goal was to show that one was more effective than the other, and the results don't show that. they are just as effective as one another.
But in practical terms, being the same could mean being better. We'll see what people have to say next week, in those ASCO round-ups, but there are a lot of Lymphoma experts who think we are moving away from chemo, and a lot of Lymphoma patients who paralyzed by the word "chemotherapy." Any treatment that is not chemo, but does as good a job (whatever the side effects) will be really attractive to those groups.
I am really curious about how the Lymphoma community will react to all of this.
For me, despite the "non-superiority" and the "similar efficacy but different safety profile," I think it's good news. Puppy dog that I am, I think choices are good for us, and if this presents a legitimate choice, so much the better.
I'm sure we'll be hearing more about this in the next few weeks.
Tuesday, May 29, 2018
Thursday, May 24, 2018
More Success for RIT for Follicular Lymphoma
There has been a lot of stuff written lately about RadioImmunoTherapy -- at least, more than I would have expected, given how difficult it is in the U.S. to get RIT. We no longer have Bexxar as an option, and Zevalin is hanging on despite being very underused, given its successes.
In January, I wrote about the great long-term results that RIT was showing in one study. Then, in March, I wrote about some data for the newer RIT called Betalutin. There's at least one abstract for RIT research in Follicular Lymphoma that's being presented at ASCO this year (more on that soon).
And a few weeks ago, Hematological Oncology published "Management of Newly Diagnosed High‐Risk and Intermediate‐Risk Follicular Lymphoma with 90Y Ibritumomab Tiuxetan in a Phase II Study."
In this phase II trial, 33 patients with high-risk or intermediate-risk FL were given R-CHOP , followed by Zevalin, and then 2 years of Rituxan Maintenance. (The abstract that I link to doesn't describe what "intermediate-risk and high-risk FL means, but the clinical trial details do. They used FLIPI scores of 2-5. I won't get into what FLIPI is here,Three months post radio‐immunotherapy, 28/33 (85%) patients had achieved complete response including 6 patients who had only a partial response to chemo‐immunotherapy and converted to complete response after radio‐immunotherapy. The 5‐year progression‐free survival for intermediate and high risk was 79% and 58%, respectively. but I'll send you to Lymphomation.org if you want to learn more.)
The results: Intermediate-risk patients had a 5 year Overall Survival of 88%, and high-risk was 85%. Pretty good results.
The 5 year Progression-Free Survival was 79% for Intermediate and 58% for high.
Three months after RIT, 85% of the patients (28 of 33) had a Complete Response, including 6 who had only had a Partial response after the R-CHOP.
Again, all pretty good.
Naturally, there were side effects, as one would expect from so much treatment. Most were manageable, though there were some harsher ones, including thrombocytopenia (low platelet levels) and neutropenia (low white blood cell levels), and one patient developed Myelodysplastic Syndrome, which cayuses abnormal blood cells.
Still, the reserachers believe the approach deserves further study (perhaps a phase III trial).
Of course, the usual precautions apply here -- it's a phase II trial, with only 33 patients, which is a very small number.
It's also kind of an older trial, begun in 2011. The upside of that is, we're getting some important long-term results. The downside is, FLIPI seems a little less sophisticated than some other ways of measuring high-risk. It would be interesting to see how this treatment would work on EFS24 patients -- in the last couple of years, it has been widely recognized that patients whose disease gets worse within 24 months after they receive Immunochemotherapy (something like R-CHOP or R-B). FLIPI is fine, but it doesn't seem as accurate as EFS24 in labeling high-risk patients. For example, I have a FLIPI score of 2, Intermediate, and I would have qualified for this study, but my disease is very different from someone with EFS24.
All of that said, this is just more evidence that RIT has a place in the treatment options for Follicular Lymphoma. It's not easy to administer (though regulations in the U.S. could make it easier), it is effective in the long-term, and it is reasonably safe.
Let's hope changes are made in the U.S. that make it more available, and that it remains available to the rest of the world.
In January, I wrote about the great long-term results that RIT was showing in one study. Then, in March, I wrote about some data for the newer RIT called Betalutin. There's at least one abstract for RIT research in Follicular Lymphoma that's being presented at ASCO this year (more on that soon).
And a few weeks ago, Hematological Oncology published "Management of Newly Diagnosed High‐Risk and Intermediate‐Risk Follicular Lymphoma with 90Y Ibritumomab Tiuxetan in a Phase II Study."
In this phase II trial, 33 patients with high-risk or intermediate-risk FL were given R-CHOP , followed by Zevalin, and then 2 years of Rituxan Maintenance. (The abstract that I link to doesn't describe what "intermediate-risk and high-risk FL means, but the clinical trial details do. They used FLIPI scores of 2-5. I won't get into what FLIPI is here,Three months post radio‐immunotherapy, 28/33 (85%) patients had achieved complete response including 6 patients who had only a partial response to chemo‐immunotherapy and converted to complete response after radio‐immunotherapy. The 5‐year progression‐free survival for intermediate and high risk was 79% and 58%, respectively. but I'll send you to Lymphomation.org if you want to learn more.)
The results: Intermediate-risk patients had a 5 year Overall Survival of 88%, and high-risk was 85%. Pretty good results.
The 5 year Progression-Free Survival was 79% for Intermediate and 58% for high.
Three months after RIT, 85% of the patients (28 of 33) had a Complete Response, including 6 who had only had a Partial response after the R-CHOP.
Again, all pretty good.
Naturally, there were side effects, as one would expect from so much treatment. Most were manageable, though there were some harsher ones, including thrombocytopenia (low platelet levels) and neutropenia (low white blood cell levels), and one patient developed Myelodysplastic Syndrome, which cayuses abnormal blood cells.
Still, the reserachers believe the approach deserves further study (perhaps a phase III trial).
Of course, the usual precautions apply here -- it's a phase II trial, with only 33 patients, which is a very small number.
It's also kind of an older trial, begun in 2011. The upside of that is, we're getting some important long-term results. The downside is, FLIPI seems a little less sophisticated than some other ways of measuring high-risk. It would be interesting to see how this treatment would work on EFS24 patients -- in the last couple of years, it has been widely recognized that patients whose disease gets worse within 24 months after they receive Immunochemotherapy (something like R-CHOP or R-B). FLIPI is fine, but it doesn't seem as accurate as EFS24 in labeling high-risk patients. For example, I have a FLIPI score of 2, Intermediate, and I would have qualified for this study, but my disease is very different from someone with EFS24.
All of that said, this is just more evidence that RIT has a place in the treatment options for Follicular Lymphoma. It's not easy to administer (though regulations in the U.S. could make it easier), it is effective in the long-term, and it is reasonably safe.
Let's hope changes are made in the U.S. that make it more available, and that it remains available to the rest of the world.
Sunday, May 20, 2018
ASCO: 5F9 Follow-Up
The abstracts for the ASCO meeting are out, and the Follicular Lymphoma abstracts are available here.
The ASCO meeting (ASCO stands for American Society of Clinical Oncology) is one of the two big meetings that I follow every year. The other one is ASH (American Society of Hematology). They occur about 6 months apart. There are lots of other big meetings where researchers present their findings about blood cancer, but these two often have good stuff to get excited about.
I don't go to the meetings, which would be a different experience -- hearing questions and follow-ups, and maybe getting more up-to-date data -- but reading the abstracts, which summarize the research being presented, is usually enough to get a sense of what's exciting.
That's especially true when Lymphoma experts get on Twitter and YouTube in the days right after the meeting and talk about what excited them. I always get a thrill out of hearing experts get excited about things.
In my last post, I talked about the FDA Fast Tracking a new treatment called 5F9, which targets the CD47 protein on the surface of cells. The press release for the Fast Tracking said that data would be released soon -- I took a guess and figured it would be released at ASCO.
Sure enough, that's it. I still haven't had a chance to explore the ASCO abstracts, so thanks to William for leaving a link to the abstract in the comments of my last post. (He also emailed me a link to the abstract for the CAR-T trial that his wife has been very successfully involved in -- look for that soon.)
The ASCO session for 5F9 is called "Activity and tolerabilty of the first-in-class anti-CD47 antibody Hu5F9-G4 with rituximab tolerated in relapsed/refractory non-Hodgkin lymphoma: Initial phase 1b/2 results."
The presentation looks at results from a phase 1b/phase 2 clinical trial. Phase 1 trials usually focus on safety -- figuring out how much of a treatment to give to a patient to be safe but still effective. [We should all thank those folks in phase 1 trials who are willing to be tested this way.]
Phase 2 looks at efficacy -- how well the treatment does, compared to other accepted treatments -- on a small group of patients. If the phase 2 results show that it's effective, the phase 3 trial will involve a larger group of patients. [While we're at it, let's thank those in phase 2 and 3 trials, too.]
So the 5F9 trial looks at safety and efficacy -- phase 1b and 2. Patients involved had Diffuse Large B Cell Lymphoma (15 patients) and Follicular Lymphoma (7 patients). 22 total is a very small number for a trial, so keep that in mind.
Patients were "heavily pre-treated" and refractory or resistant to Rituxan -- the median number of treatments before this trial was 4, and Rituxan wasn't working anymore. The patients were given 5F9 and Rituxan (even though it wasn't working, the combination with 5F9 might work differently).
Results were good -- overall, no matter the type of Lymphoma or the dose given, there was a 50% Overall Response, with a 32% Complete Response. For the 7 FL patients, 5 had a response (71%), with 3 having a Complete Response (43%). In the whole trial, 90% of patients who had a response continued that response, with a median of 4.4 months, and one going for over 13 months.
As for safety, the side effects were manageable. Anemia (low red blood cells) was a particular concern, but they seemed to be able to control it. (CD47 is a self-marker for red blood cells, so 5F9 would probably target them the way it would with a cancer cell.)
So, good results -- good enough for the FDA to fast Track this treatment. As I said last time, Fast tracking doesn't mean it will necessarily get a review anytime soon, but it does mean that the FDA recognizes that there is a need that this treatment might fill, and it will give it some extra help to get to the approval stage.
I'll say it again -- while it's promising, it's also really early. 22 patients (and only 7 for FL) isn't going to really tell us how well this works. But the phase 2 trial is ongoing (info is here) so we'll get more answers in time.
I have a couple of posts planned before I get to the ASCO stuff, so stay tuned. Lots going on in the world of Follicular Lymphoma these days.
The ASCO meeting (ASCO stands for American Society of Clinical Oncology) is one of the two big meetings that I follow every year. The other one is ASH (American Society of Hematology). They occur about 6 months apart. There are lots of other big meetings where researchers present their findings about blood cancer, but these two often have good stuff to get excited about.
I don't go to the meetings, which would be a different experience -- hearing questions and follow-ups, and maybe getting more up-to-date data -- but reading the abstracts, which summarize the research being presented, is usually enough to get a sense of what's exciting.
That's especially true when Lymphoma experts get on Twitter and YouTube in the days right after the meeting and talk about what excited them. I always get a thrill out of hearing experts get excited about things.
In my last post, I talked about the FDA Fast Tracking a new treatment called 5F9, which targets the CD47 protein on the surface of cells. The press release for the Fast Tracking said that data would be released soon -- I took a guess and figured it would be released at ASCO.
Sure enough, that's it. I still haven't had a chance to explore the ASCO abstracts, so thanks to William for leaving a link to the abstract in the comments of my last post. (He also emailed me a link to the abstract for the CAR-T trial that his wife has been very successfully involved in -- look for that soon.)
The ASCO session for 5F9 is called "Activity and tolerabilty of the first-in-class anti-CD47 antibody Hu5F9-G4 with rituximab tolerated in relapsed/refractory non-Hodgkin lymphoma: Initial phase 1b/2 results."
The presentation looks at results from a phase 1b/phase 2 clinical trial. Phase 1 trials usually focus on safety -- figuring out how much of a treatment to give to a patient to be safe but still effective. [We should all thank those folks in phase 1 trials who are willing to be tested this way.]
Phase 2 looks at efficacy -- how well the treatment does, compared to other accepted treatments -- on a small group of patients. If the phase 2 results show that it's effective, the phase 3 trial will involve a larger group of patients. [While we're at it, let's thank those in phase 2 and 3 trials, too.]
So the 5F9 trial looks at safety and efficacy -- phase 1b and 2. Patients involved had Diffuse Large B Cell Lymphoma (15 patients) and Follicular Lymphoma (7 patients). 22 total is a very small number for a trial, so keep that in mind.
Patients were "heavily pre-treated" and refractory or resistant to Rituxan -- the median number of treatments before this trial was 4, and Rituxan wasn't working anymore. The patients were given 5F9 and Rituxan (even though it wasn't working, the combination with 5F9 might work differently).
Results were good -- overall, no matter the type of Lymphoma or the dose given, there was a 50% Overall Response, with a 32% Complete Response. For the 7 FL patients, 5 had a response (71%), with 3 having a Complete Response (43%). In the whole trial, 90% of patients who had a response continued that response, with a median of 4.4 months, and one going for over 13 months.
As for safety, the side effects were manageable. Anemia (low red blood cells) was a particular concern, but they seemed to be able to control it. (CD47 is a self-marker for red blood cells, so 5F9 would probably target them the way it would with a cancer cell.)
So, good results -- good enough for the FDA to fast Track this treatment. As I said last time, Fast tracking doesn't mean it will necessarily get a review anytime soon, but it does mean that the FDA recognizes that there is a need that this treatment might fill, and it will give it some extra help to get to the approval stage.
I'll say it again -- while it's promising, it's also really early. 22 patients (and only 7 for FL) isn't going to really tell us how well this works. But the phase 2 trial is ongoing (info is here) so we'll get more answers in time.
I have a couple of posts planned before I get to the ASCO stuff, so stay tuned. Lots going on in the world of Follicular Lymphoma these days.
Tuesday, May 15, 2018
5F9 Given Fast Track Review for FL
Great news last week for 5F9 -- the FDA has granted it Fast Track Review for Follicular Lymphoma.
What? You haven't heard of 5F9?
To be honest, I hadn't either, until last week.
When a treatment is given a Fast Track designation by the FDA, it means the FDA believes it will address a "unmet medical need" for a "serious condition." Because of this, the designation means the FDA will give some extra help in the development of the treatment (like extra meetings and written communication with the FDA and advice on clinical trial design) and possible faster review than usual.
The idea is, if the treatment has the potential to do something great, the FDA wants to get it to patients as quickly and easily as possible (assuming it is shown to be effective and safe, of course).
Fast Track also kind of implies that the treatment is still fairly early in the process, since there will be extra help for development.
And that's probably why you've never heard of it (and why I've never heard of it, even though I like to think of myself as pretty well informed on these things) -- 5F9 got the designation based on results of a phase 1b/phase 2 clinical trial -- still very early.
5F9 is a monoclonal antibody. (I assume, if it is approved, it will get a new name, probably something with at least one X, Y, or Z in it.)
For comparison, think of our old pal Rituxan -- also a monoclonal antibody. Rituxan targets CD20, a protein on the surface of B cells. When Rituxan finds CD20, it helps to destroy the cell.
Same with 5F9, except it targets the CD47 protein. CD47 is a protein found on all cells, but it is over-expressed on certain cells -- that is, too many copies of it get made.
That's important, because CD47 has a special job. It is known as a "marker of self." In other words, when immune cells go around looking for cells that don't belong (usually things like viruses and bacteria), when they come across CD47, it's a signal that the cell belongs, and shouldn't be attacked. (I really like that, when I was reading up on CD47, several articles from medical journals kept calling CD47 a "don't-eat-me signal." That's good, clear writing.)
So that's the deal -- 5F9 looks for CD47 and takes out those cells. Get rid of the "don't eat me" signal, and the immune cells go to work.
Just how effective is it?
No idea. The results from the phase 1b trial will be released sometime in the next few weeks. (Maybe during the ASCO conference next month?)
5F9 looks like it could do some excellent things. The Fast Track covers Follicular Lymphoma and Diffuse Large B Cell Lymphoma (DLBCL), and there are also trials going on for Ovarian Cancer, Bladder Cancer, Colorectal Cancer, and an aggressive Leukemia.
Of course, it's early in the process -- even a process that might be sped up a little. And a phase 1b trial is going to involve a fairly small number of patients.
Still, I'm looking forward to hearing more detail in the next few weeks. I assume it will be good news, given the FDA's encouragement, but it will be good to see actual data on how effective and safe it is.
What? You haven't heard of 5F9?
To be honest, I hadn't either, until last week.
When a treatment is given a Fast Track designation by the FDA, it means the FDA believes it will address a "unmet medical need" for a "serious condition." Because of this, the designation means the FDA will give some extra help in the development of the treatment (like extra meetings and written communication with the FDA and advice on clinical trial design) and possible faster review than usual.
The idea is, if the treatment has the potential to do something great, the FDA wants to get it to patients as quickly and easily as possible (assuming it is shown to be effective and safe, of course).
Fast Track also kind of implies that the treatment is still fairly early in the process, since there will be extra help for development.
And that's probably why you've never heard of it (and why I've never heard of it, even though I like to think of myself as pretty well informed on these things) -- 5F9 got the designation based on results of a phase 1b/phase 2 clinical trial -- still very early.
5F9 is a monoclonal antibody. (I assume, if it is approved, it will get a new name, probably something with at least one X, Y, or Z in it.)
For comparison, think of our old pal Rituxan -- also a monoclonal antibody. Rituxan targets CD20, a protein on the surface of B cells. When Rituxan finds CD20, it helps to destroy the cell.
Same with 5F9, except it targets the CD47 protein. CD47 is a protein found on all cells, but it is over-expressed on certain cells -- that is, too many copies of it get made.
That's important, because CD47 has a special job. It is known as a "marker of self." In other words, when immune cells go around looking for cells that don't belong (usually things like viruses and bacteria), when they come across CD47, it's a signal that the cell belongs, and shouldn't be attacked. (I really like that, when I was reading up on CD47, several articles from medical journals kept calling CD47 a "don't-eat-me signal." That's good, clear writing.)
So that's the deal -- 5F9 looks for CD47 and takes out those cells. Get rid of the "don't eat me" signal, and the immune cells go to work.
Just how effective is it?
No idea. The results from the phase 1b trial will be released sometime in the next few weeks. (Maybe during the ASCO conference next month?)
5F9 looks like it could do some excellent things. The Fast Track covers Follicular Lymphoma and Diffuse Large B Cell Lymphoma (DLBCL), and there are also trials going on for Ovarian Cancer, Bladder Cancer, Colorectal Cancer, and an aggressive Leukemia.
Of course, it's early in the process -- even a process that might be sped up a little. And a phase 1b trial is going to involve a fairly small number of patients.
Still, I'm looking forward to hearing more detail in the next few weeks. I assume it will be good news, given the FDA's encouragement, but it will be good to see actual data on how effective and safe it is.
Saturday, May 12, 2018
Finding Hope Among the Thorns of Cancer
I had a piece published this week on The Mighty that I thought I'd share with you.
It's called "Finding Hope Among the Thorns of Cancer."
As you all know, Hope is important to me. It's easy to lose, too. Follicular Lymphoma can be overwhelming, sometimes in ways we don't expect it to be.
It's helpful to me to have reminders of Hope that I can see.
This story is about one of them.
I hope you like it.
It's called "Finding Hope Among the Thorns of Cancer."
As you all know, Hope is important to me. It's easy to lose, too. Follicular Lymphoma can be overwhelming, sometimes in ways we don't expect it to be.
It's helpful to me to have reminders of Hope that I can see.
This story is about one of them.
I hope you like it.
Wednesday, May 9, 2018
Rituxan Biosimilar Setback
One of the proposed biosimilars for Rituxan got some potentially bad news this week from the FDA -- approval has been delayed.
A reminder about biosimilars and why they matter for Follicular Lymphoma patients:
Think of biosimilars as like "generic drugs." A drug that could be used for, say, treating a cold, has exclusive rights for a set number of years. The company that developed the drug gets the chance to get back some of the money they spent on that development by being the only company that can make the drug. After that time expires, other companies can develop their own generic versions. They are usually cheaper because they didn't need to spend money on developing the drug.
But generic drugs are fairly easy to make. The drug has a chemical formula that can be copied.
Biosimilars are sort of like generic drugs, in that another company has developed a treatment and then has the right to be the only company to sell it for a set number of years. However, biosimilars aren't drugs that can be copied by figuring out the chemical formula. As the name implied, they are made from living things, and that makes it a whole lot harder to copy them. But like generic drugs, when they can be shown to be as safe and effective as the original, they should be cheaper.
But dealing with living things is a lot harder than copying a formula.
So that's where we are with this proposed biosimilar. The FDA issued a Complete Response Letter saying it will not approve the application (at least not yet).
[To be clear, a "Complete Response Letter" doesn't have anything to do with the term "Complete Response" that describes a patient who has gone into remission from a treatment. A Complete Response Letter means the FDA has completed its review of an application for approval of a treatment, and is sending bad news. Same words, but different meanings. Unnecessarily confusing, if you ask me.]
I haven't seen the Complete Response Letter anywhere (I don't know if they are made public), so I don't know what exactly the FDA was concerned about.
The bad news is, this means a possibly cheaper Rituxan biosimilar won't be available as soon as many would have liked. Cheaper treatments (assuming they are still safe and effective) are good for patients.
The good news is, the company has not given up on getting the biosimilar approved. In their press release, they say that they are "committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible." So their plan is to address the FDA's concerns and try again.
This biosimilar has already been approved for use in Europe, so there must be some good to it.
In the meantime, we as patients can hope that new treatments, and cheaper versions of old ones, continue to be developed and made available to us.
A reminder about biosimilars and why they matter for Follicular Lymphoma patients:
Think of biosimilars as like "generic drugs." A drug that could be used for, say, treating a cold, has exclusive rights for a set number of years. The company that developed the drug gets the chance to get back some of the money they spent on that development by being the only company that can make the drug. After that time expires, other companies can develop their own generic versions. They are usually cheaper because they didn't need to spend money on developing the drug.
But generic drugs are fairly easy to make. The drug has a chemical formula that can be copied.
Biosimilars are sort of like generic drugs, in that another company has developed a treatment and then has the right to be the only company to sell it for a set number of years. However, biosimilars aren't drugs that can be copied by figuring out the chemical formula. As the name implied, they are made from living things, and that makes it a whole lot harder to copy them. But like generic drugs, when they can be shown to be as safe and effective as the original, they should be cheaper.
But dealing with living things is a lot harder than copying a formula.
So that's where we are with this proposed biosimilar. The FDA issued a Complete Response Letter saying it will not approve the application (at least not yet).
[To be clear, a "Complete Response Letter" doesn't have anything to do with the term "Complete Response" that describes a patient who has gone into remission from a treatment. A Complete Response Letter means the FDA has completed its review of an application for approval of a treatment, and is sending bad news. Same words, but different meanings. Unnecessarily confusing, if you ask me.]
I haven't seen the Complete Response Letter anywhere (I don't know if they are made public), so I don't know what exactly the FDA was concerned about.
The bad news is, this means a possibly cheaper Rituxan biosimilar won't be available as soon as many would have liked. Cheaper treatments (assuming they are still safe and effective) are good for patients.
The good news is, the company has not given up on getting the biosimilar approved. In their press release, they say that they are "committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible." So their plan is to address the FDA's concerns and try again.
This biosimilar has already been approved for use in Europe, so there must be some good to it.
In the meantime, we as patients can hope that new treatments, and cheaper versions of old ones, continue to be developed and made available to us.
Sunday, May 6, 2018
Mental Health and Cancer
If you've been reading for a while, you know how important I think it is to talk about the emotional aspects of Follicular Lymphoma. For many of us with FL, physical symptoms are not a big problem, at least not right away, or all the time. We are able to watch and wait, keeping an eye on physical symptoms until they require treatment.
But the emotional symptoms don't go away -- worry, fear, guilt. They need to be taken care of, maybe even sooner than the physical symptoms.
May is Mental Health Awareness Month. And one of the great things I have learned at HealtheVoices over the last two years is that Mental Health is not only important, but often ignored, both by people and their doctors. There's a stigma that is attached to having Mental Health issues -- we don't have any problem with going to a doctor to get our physical symptoms looked at (whether it's cancer or just a bad cold), but we're reluctant to see someone about mental symptoms.
I think that's especially true of men, though it's certainly true of women, too. Certainly in the U.S., we are taught to "suck it up" and "get over it" when we are feeling overwhelming negative emotions. I tell myself those things, and I tell my kids them too. But sometimes, it's the wrong thing to say. Sometimes, that leads to not getting help for our Mental Health.
One of the people I met at HealtheVoices last year (and again this year) is Al Levin, an advocate for Mental Health patients. Al writes a blog and produces a podcast (The Depression Files) with new episodes twice a month, that focus on Mental Health and the importance of taking away the stigma that comes with it. He told me stories about being diagnosed with depression, and wearing a hat and sunglasses to the pharmacy to get his medication, afraid of the shame that would come if someone saw him, and then tearing the receipt into small pieces so no one could see what his prescription was for.
Imagine how horrible our lives as Follicular Lymphoma patients would be if there was that same stigma attached to Rituxan. And imagine how many FL patients would just take their chances with not getting treatment, and how disastrous the results would be.
I'm not just saying that it's bad that we as a society don't have a good attitude about Mental Health, although I think that's true.
I also think it's important to remind cancer patients that we need to take care of our mental symptoms, and not just our physical ones.
There are lots of ways that cancer can affect Mental Health. Three of the most common ways are Anxiety, Depression, and Grief. But there are certainly others.
The first step in dealing with them is to let someone know how you are feeling -- a partner or family member, a friend or a doctor. Find out about Mental Health services available through your oncologist's office -- support groups, social workers, therapists or counselors.
But whatever you do, if you're feeling bad, don't keep it to yourself. there are lots of ways to get help.
I asked Al if I could repost something he wrote on his blog a couple of years ago, and he kindly said I could. Please read it and share it, and remind people (whether they are cancer patients or not) that there's no shame in getting help.
********************************
From A Mental Health Blog by Al Levin, May 2016:
Do what you can to support the awareness of mental illnesses and the elimination of the stigma!
But the emotional symptoms don't go away -- worry, fear, guilt. They need to be taken care of, maybe even sooner than the physical symptoms.
May is Mental Health Awareness Month. And one of the great things I have learned at HealtheVoices over the last two years is that Mental Health is not only important, but often ignored, both by people and their doctors. There's a stigma that is attached to having Mental Health issues -- we don't have any problem with going to a doctor to get our physical symptoms looked at (whether it's cancer or just a bad cold), but we're reluctant to see someone about mental symptoms.
I think that's especially true of men, though it's certainly true of women, too. Certainly in the U.S., we are taught to "suck it up" and "get over it" when we are feeling overwhelming negative emotions. I tell myself those things, and I tell my kids them too. But sometimes, it's the wrong thing to say. Sometimes, that leads to not getting help for our Mental Health.
One of the people I met at HealtheVoices last year (and again this year) is Al Levin, an advocate for Mental Health patients. Al writes a blog and produces a podcast (The Depression Files) with new episodes twice a month, that focus on Mental Health and the importance of taking away the stigma that comes with it. He told me stories about being diagnosed with depression, and wearing a hat and sunglasses to the pharmacy to get his medication, afraid of the shame that would come if someone saw him, and then tearing the receipt into small pieces so no one could see what his prescription was for.
Imagine how horrible our lives as Follicular Lymphoma patients would be if there was that same stigma attached to Rituxan. And imagine how many FL patients would just take their chances with not getting treatment, and how disastrous the results would be.
I'm not just saying that it's bad that we as a society don't have a good attitude about Mental Health, although I think that's true.
I also think it's important to remind cancer patients that we need to take care of our mental symptoms, and not just our physical ones.
There are lots of ways that cancer can affect Mental Health. Three of the most common ways are Anxiety, Depression, and Grief. But there are certainly others.
The first step in dealing with them is to let someone know how you are feeling -- a partner or family member, a friend or a doctor. Find out about Mental Health services available through your oncologist's office -- support groups, social workers, therapists or counselors.
But whatever you do, if you're feeling bad, don't keep it to yourself. there are lots of ways to get help.
I asked Al if I could repost something he wrote on his blog a couple of years ago, and he kindly said I could. Please read it and share it, and remind people (whether they are cancer patients or not) that there's no shame in getting help.
********************************
From A Mental Health Blog by Al Levin, May 2016:
It’s Mental Health Awareness Month????
Did you know that the month of May is
Mental Health Awareness Month? It seems to me that few people realize
that May is Mental Health Awareness Month. I believe that this speaks
volumes about the long road we have to go regarding awareness, and
therefore, the anti-stigma work, around mental health. According to
Wikipedia, “Mental Health Awareness Month
has been observed in May in the United States since 1949.” How is it
that so many people are still unaware of its existence? It was just
last April 22 that the New York Times ran an article titled, “US Suicide Rate Surges to a 30-Year High”,
yet it is almost as though you need to be a part of a secret club in
order to find out that May is Mental Health Awareness Month.
Last year I remember having the
conversation with a therapist at a Behavioral Health clinic who had no
idea that May was Mental Health Month. I did a Google search today for
“Behavioral Health Clinic” and of the first ten clinics/organizations
that I clicked on, not one of them mentioned that May is Mental Health Awareness Month. How ironic is it that so few people are aware of a month that has been dedicated to mental health awareness for 67 years?
What can you do? Here some thoughts that I have around supporting the fact that May is Mental Health Awareness month:
- Share your story in writing. There are many websites where you can share your story. Here are just a couple of them: Mental Health America and The Mighty.
- Request to set up a presentation at your company/organization to promote mental health awareness and support. NAMI has many affiliates that offer these services
- Post flyers at your work place that offer resources for those with mental illness
- Offer employees to share artwork and poetry and post them in a public location.
Do what you can to support the awareness of mental illnesses and the elimination of the stigma!
Thursday, May 3, 2018
Another CAR-T Approval for Transformed FL
The FDA has approved a second CAR-T treatment for some aggressive B Cell Lymphomas, including transformed Follicular Lymphoma.
The treatment is called Kymriah. It has already been approved for some Leukemia patients, and now has been approved for DLBCL (Diffuse Large B-cell Lymphoma), high grade B-Cell Lymphoma, or Follicular Lymphoma that has transformed into DLBCL. Patients must have also had at least two other treatments that stopped working (or didn't work at all).
This approval means that there are now two CAR-T treatments that are available for patients in those same situations (aggressive B Cell Lymphomas after two failed treatments). The other, Yescarta, was approved a few months ago.
One of the big criticisms of CAR-T treatments has been the cost. Kymriah, when it was approved for Leukemia, was priced at $475,000 (though the manufacturer announced that if it didn't work the cost would be free). Yescarta was priced at $373,000. With the new approval, Kymriah will now be priced as the same as Yescarta, at $373,000 for either one of them (though without the money-back guarantee).
What I find interesting is that, looking just at the numbers, Yescarta seems to be superior to Kymriah, though Kymriah seems safer. The announcements of the Kymriah approval said that it had a 50% Overall Response (32% Complete Response and 18% Partial Response), and that 23% developed Cytokine Release Syndrome, a potentially serious side effect of CAR-T, as well as other side effects.
Yescarta, on the other hand, had a higher success rate -- about 76% Overall Response (50% CR and 26% PR), though it had much higher numbers of patients with CRS and other serious side effects. (It's important to note that CRS, probably the most serious of the side effects of CAR-T, seems to be more controllable now than with some patients in earlier parts of trials).
Choice is good. I hope that, in the months ahead, we'll get a better sense of which of these two treatments is better for which patients.
If you are interested in learning more about CAR-T, I will, as always, point you to the CAR-T and Follicular Non-Hodgkin's Lymphoma blog.
It's run by a CAR-T patient and a CAR-T caregiver, and will give you some excellent links to information about CAR-T. The latest posts will bring you some basic information about CAR-T, and some research on why some people don't get a response. Good stuff.
While the only Follicular Lymphoma that CAR-T is approved for right now is transformed FL, there are trails going on for less aggressive types. We'll keep an eye on them and report here (though Ben and William might beat me to it).
The treatment is called Kymriah. It has already been approved for some Leukemia patients, and now has been approved for DLBCL (Diffuse Large B-cell Lymphoma), high grade B-Cell Lymphoma, or Follicular Lymphoma that has transformed into DLBCL. Patients must have also had at least two other treatments that stopped working (or didn't work at all).
This approval means that there are now two CAR-T treatments that are available for patients in those same situations (aggressive B Cell Lymphomas after two failed treatments). The other, Yescarta, was approved a few months ago.
One of the big criticisms of CAR-T treatments has been the cost. Kymriah, when it was approved for Leukemia, was priced at $475,000 (though the manufacturer announced that if it didn't work the cost would be free). Yescarta was priced at $373,000. With the new approval, Kymriah will now be priced as the same as Yescarta, at $373,000 for either one of them (though without the money-back guarantee).
What I find interesting is that, looking just at the numbers, Yescarta seems to be superior to Kymriah, though Kymriah seems safer. The announcements of the Kymriah approval said that it had a 50% Overall Response (32% Complete Response and 18% Partial Response), and that 23% developed Cytokine Release Syndrome, a potentially serious side effect of CAR-T, as well as other side effects.
Yescarta, on the other hand, had a higher success rate -- about 76% Overall Response (50% CR and 26% PR), though it had much higher numbers of patients with CRS and other serious side effects. (It's important to note that CRS, probably the most serious of the side effects of CAR-T, seems to be more controllable now than with some patients in earlier parts of trials).
Choice is good. I hope that, in the months ahead, we'll get a better sense of which of these two treatments is better for which patients.
If you are interested in learning more about CAR-T, I will, as always, point you to the CAR-T and Follicular Non-Hodgkin's Lymphoma blog.
It's run by a CAR-T patient and a CAR-T caregiver, and will give you some excellent links to information about CAR-T. The latest posts will bring you some basic information about CAR-T, and some research on why some people don't get a response. Good stuff.
While the only Follicular Lymphoma that CAR-T is approved for right now is transformed FL, there are trails going on for less aggressive types. We'll keep an eye on them and report here (though Ben and William might beat me to it).
Tuesday, May 1, 2018
HealtheVoices 2018
This past weekend, I once again participated in HealtheVoices -- a summit of online patient advocates.
That's Health-E-Voices -- advocates with "healthy voices" but who also use their "health e-voices" to help support and educate others who share their health conditions.
The summit included 122 advocates for over 40 health conditions like Diabetes, Multiple Sclerosis, HIV, Mental Health, Inflammatory Bowel Disease, Psoriasis, Chronic Pain, and several types of cancer (including, of course, Follicular Lymphoma -- I think I represented us well).
(By the way, Healthevoices is sponsored by Janssen Pharmaceuticals, who paid for my travel expenses, though all thoughts and opinions about the summit are my own.)
Over the weekend, we learned a lot about social media (there were people from YouTube and Twitter and a few online health sites), the healing power of humor, valuing differences -- and about ourselves and each other.
This is the second year I have been invited to go, and I was really happy to be back. Last year was special to me. Honestly, before last year, I wouldn't have even considered myself an "advocate" -- I was just a guy with cancer and a blog.
And now, a year later, I've certainly kept up with the blog, but I've tried to find other ways to reach out to Follicular Lymphoma patients, to support them, to learn more. I'm on Twitter now (find me @lymphomaniac). I use it to share information that I find helpful and important, but I also use it to connect with very smart people and learn more about our disease, and share what I learn with you.
And I've done more writing. You can find articles that I have written on The Mighty, a site where patients of all kinds share their stories.
I made a cool video for WEGO Health that introduced a WebMD slide show. I wrote an article on the power of cancer humor for Patient Have Power magazine (sorry I can't link to that one -- it was a print magazine from Clara Health). I was the first guest blogger for the Savvy Co-op blog.
So HealtheVoices 2017 was really great for me. It made me a better advocate. In fact, it made an advocate, period.
This year, I learned even more about some of the new ways I can help other patients. We'll see what comes of it. I'll keep you updated about any new and interesting ways you can find me online.
What's more important, though, is that it gave me a boost. It's hard to think about cancer every day. Hanging out with a whole bunch of really inspiring people for a weekend gave me some energy to keep going.
(These people were amazing. They are a model for going through something very hard, and not only coming through it, but turning it into something amazing.)
One of the best things about the weekend was getting to meet some other cancer advocates. A bunch of us were asked to review some online materials and give our opinions. (I'll share more about that some other time.) It was great to hear their stories -- no matter what kind of cancer, we all have some experiences in common -- and it was great to see the way they advocated so fiercely for their communities.
Let me tell you about some of them:
There's Kyle, who runs Check 15, a monthly reminder to check yourself for possible signs of cancer. Very funny videos make it easier to deal with uncomfortable topics -- share them with family and friends.
And there's Racheli, a Hodgkin's Lymphoma survivor who writes a column for Lymphoma News Today and makes videos about her experiences (as a patient and about her life after treatment).
And Ben, who runs Cuck Fancer, which helps young cancer survivors to get their lives back.
And Jen, who helps Breast Cancer patients and moms who have cancer.
And Justin, who is trying to change the conversation about men's health and testicular cancer.
And Michele, who survived a slow-growing, indolent Leukemia to "dance through life."
And Rick, who founded the Answer Cancer Foundation to provide support to many cancer patients.
And that's just a few of the great people I met this weekend.
It wasn't just about cancer. I met so many advocates, and learned about their conditions.
I like to think of myself as a pretty empathetic person -- I can understand and care about what other people are going through. But HealtheVoices makes me even more empathetic. It makes me want to go a little deeper into learning how other people feel.
That's especially true of the mental health advocates who were there. As you know, I take special interest in the emotional lives of FL patients. Talking to mental health advocates gave me some insight into how people think, and feel, and react.
And maybe that's the biggest lesson I learned in my two years at HealtheVoices. It was something I've heard before, and was said again this weekend:
Be kind to other people. You don't know what they're going through.
Thanks, as always, for reading. I look forward to sharing more with you.
That's Health-E-Voices -- advocates with "healthy voices" but who also use their "health e-voices" to help support and educate others who share their health conditions.
The summit included 122 advocates for over 40 health conditions like Diabetes, Multiple Sclerosis, HIV, Mental Health, Inflammatory Bowel Disease, Psoriasis, Chronic Pain, and several types of cancer (including, of course, Follicular Lymphoma -- I think I represented us well).
(By the way, Healthevoices is sponsored by Janssen Pharmaceuticals, who paid for my travel expenses, though all thoughts and opinions about the summit are my own.)
Over the weekend, we learned a lot about social media (there were people from YouTube and Twitter and a few online health sites), the healing power of humor, valuing differences -- and about ourselves and each other.
This is the second year I have been invited to go, and I was really happy to be back. Last year was special to me. Honestly, before last year, I wouldn't have even considered myself an "advocate" -- I was just a guy with cancer and a blog.
And now, a year later, I've certainly kept up with the blog, but I've tried to find other ways to reach out to Follicular Lymphoma patients, to support them, to learn more. I'm on Twitter now (find me @lymphomaniac). I use it to share information that I find helpful and important, but I also use it to connect with very smart people and learn more about our disease, and share what I learn with you.
And I've done more writing. You can find articles that I have written on The Mighty, a site where patients of all kinds share their stories.
I made a cool video for WEGO Health that introduced a WebMD slide show. I wrote an article on the power of cancer humor for Patient Have Power magazine (sorry I can't link to that one -- it was a print magazine from Clara Health). I was the first guest blogger for the Savvy Co-op blog.
So HealtheVoices 2017 was really great for me. It made me a better advocate. In fact, it made an advocate, period.
This year, I learned even more about some of the new ways I can help other patients. We'll see what comes of it. I'll keep you updated about any new and interesting ways you can find me online.
What's more important, though, is that it gave me a boost. It's hard to think about cancer every day. Hanging out with a whole bunch of really inspiring people for a weekend gave me some energy to keep going.
(These people were amazing. They are a model for going through something very hard, and not only coming through it, but turning it into something amazing.)
One of the best things about the weekend was getting to meet some other cancer advocates. A bunch of us were asked to review some online materials and give our opinions. (I'll share more about that some other time.) It was great to hear their stories -- no matter what kind of cancer, we all have some experiences in common -- and it was great to see the way they advocated so fiercely for their communities.
Let me tell you about some of them:
There's Kyle, who runs Check 15, a monthly reminder to check yourself for possible signs of cancer. Very funny videos make it easier to deal with uncomfortable topics -- share them with family and friends.
And there's Racheli, a Hodgkin's Lymphoma survivor who writes a column for Lymphoma News Today and makes videos about her experiences (as a patient and about her life after treatment).
And Ben, who runs Cuck Fancer, which helps young cancer survivors to get their lives back.
And Jen, who helps Breast Cancer patients and moms who have cancer.
And Justin, who is trying to change the conversation about men's health and testicular cancer.
And Michele, who survived a slow-growing, indolent Leukemia to "dance through life."
And Rick, who founded the Answer Cancer Foundation to provide support to many cancer patients.
And that's just a few of the great people I met this weekend.
It wasn't just about cancer. I met so many advocates, and learned about their conditions.
I like to think of myself as a pretty empathetic person -- I can understand and care about what other people are going through. But HealtheVoices makes me even more empathetic. It makes me want to go a little deeper into learning how other people feel.
That's especially true of the mental health advocates who were there. As you know, I take special interest in the emotional lives of FL patients. Talking to mental health advocates gave me some insight into how people think, and feel, and react.
And maybe that's the biggest lesson I learned in my two years at HealtheVoices. It was something I've heard before, and was said again this weekend:
Be kind to other people. You don't know what they're going through.
Thanks, as always, for reading. I look forward to sharing more with you.
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