The Journal of Clinical Oncology published a commentary on the article that I wrote about in my last post. The research article discusses the AUGMENT trial. The commentary is called "Augmenting Indolent Lymphoma Treatment Options With the Combination of Lenalidomide and Rituximab." It's written by Dr. Paul Barr from the University of Rochester.
First of all, I love a good pun in a medical journal title.
Second, and more importantly, Dr. Barr gives a little more context to where the R-squared combination might fit in to the Big Picture for Follicular Lymphoma treatment.
As Dr. Barr points out, Follicular Lymphoma treatment has become more successful since Rituxan was introduced. I have said often that, when I was diagnosed in 2008, I read the the median survival for FL patients was 8-10 years. (That was probably a low estimate taken from an older study.) As Dr. Barr points out, estimates now put the median survival at closer to 20 years. People diagnosed in their 60's (the age when most people are diagnosed) are living to the time when the general population is living. That's excellent news.
However, there is a subset of the FL population that doesn't do as well. For about 20% of patients, they receive immunochemotherapy (something like R-CHOP or R-Bendamustine), and the doisease comes back within 24 months. This group has a lower median Overall Survival than the other 80%. (Though it's important to note that neither of those groups is ever guaranteed anything -- a long life or a short one -- because statistics are about large groups, bot the individuals within those groups. Take a second to remind yourself about that.)
The people in that group might do well with a treatment that acts differently from the Rituxan or the chemo that they have already had. R-Squared might be a choice for them. While it contains Rituxan, like most immunochemotherapies, it's the other R, the Revlimid (or Lenalidomide) that is different. It's an "immunomodulatory" treatment. Basically, it works in the bone marrow, where blood cells are formed -- it encourages good cells and helps to kill off bad cells. (There's more to it than that, but that's the basics.) And when Lenalidomide is combined with Rituxan, they work together very well.
The RELEVANCE trial involved patients who had not yet received treatment. Results showed that, for this group, it worked just about as well as immunochemotherapy. But it wasn't better, so it probably won't replace immunochemo as the first choice for many patients.
The AUGMENT trial, though, looked at patients who did receive treatment. The results of that trial were good. The trial compared R-Squared to just Rituxan (no chemo added), with good results. Dr. Barr is guessing that both treatments have a place. For patients who have a relapse, but have low tumor burden, Rituxan might be a good choice. But for patients who relapse and have a more aggressive disease, R-Squared might be a good choice.
In the end, though, with a good number of choices available to Follicular Lymphoma patients, what we really need is some way to know which treatments will work best in which situations. That work has been happening, but the results are coming as quickly as we would like. Perhaps the focus right now should be on that 20% who relapse after 24 months, since their situation is more urgent. The rest of us can do OK with what is currently available.
I've been writing about R-Squared a lot lately. That's because it's been in the news a lot lately. But all of this news kind of confirms for me that all of the excitement about R-Squared for the last few years has probably been justified. Assuming we see approvals from the FDA and other regulators, my guess is that we'll see a lot more patients being treated with it, and it will become as much a part of our conversations as Rituxan, R-CHOP, and Bendamustine. Just a guess, but if oncologists are excited about it, that will probably mean they recommend it more to patients. So be prepared -- know your options when the time comes.
Wednesday, March 27, 2019
Friday, March 22, 2019
Full R-Squared Results
Earlier this month, I wrote that the R-Squared combination is going to get Priority Review from the FDA for Follicular Lymphoma patients who have already received a treatment.
R-Squared is the popular name for the combination of Rituxan and Revlimid (also known as Lenalidomide).
The Priority Review decision was based on results from the phase III AUGMENT trial. The full write up of those results is now available from the Journal of Clinical Oncology. The article is called "AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma."
The study involved 358 patients from several different countries. They all had either FL or Marginal Zone Lymphoma, another slow-growing, incurable lymphoma. All had already received at least one treatment (chemo, immunochemo, or immunotherapy, and two or more doses of Rituxan, and all had their lymphoma come back after treatment.
The patients were divided into two groups. 178 of them received R-Squared, and 180 received Rituxan plus a placebo. (This kind of direct comparison is important, and the best way to really test a new treatment against an already-established treatment. It allows the researchers to control the comparison, rather than comparing results with a study that happened 5 years before with patients that they didn't choose themselves.)
The endpoint for the study was Progression Free Survival -- essentially measuring how long it took for the disease to come back (or for the patient to die). The median PFS for the R-Squared group was 39.4 months (half of patients had an event before that, and half after that, or didn't have an event at all). For the Rituxan group, the PFS was 14.1 months. R-Squared was clearly superior.
While PFS was the main way of measuring the two treatments, there were some other endpoints for the study, and R-Squared was superior in all of them, too. Overall Survival results are "Still maturing," according to the researchers, which is good -- there haven't been enough deaths to say what the halfway point is.
As for safety, there were, of course, side effects. The R-Squared group had more patients with more serious side effects than the Rituxan group. These were already known, and seem typical (lower blood counts, nerve issues, digestive issues). there were two deaths in each group during the trial.
The conclusion to this study: R-Squared will provide another effective alternative for Follicular lymphoma patients who have had previous treatment.
As I said in my earlier post about the FDA review decision, I've been reading about R-Squared for a very long time (almost 10 years), and it's great to see the results of all the excitement that researchers have had about it for all that time.
The approval from the FDA will come sometime in the fall. Seems like chances are good for another arrow in the quiver.
R-Squared is the popular name for the combination of Rituxan and Revlimid (also known as Lenalidomide).
The Priority Review decision was based on results from the phase III AUGMENT trial. The full write up of those results is now available from the Journal of Clinical Oncology. The article is called "AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma."
The study involved 358 patients from several different countries. They all had either FL or Marginal Zone Lymphoma, another slow-growing, incurable lymphoma. All had already received at least one treatment (chemo, immunochemo, or immunotherapy, and two or more doses of Rituxan, and all had their lymphoma come back after treatment.
The patients were divided into two groups. 178 of them received R-Squared, and 180 received Rituxan plus a placebo. (This kind of direct comparison is important, and the best way to really test a new treatment against an already-established treatment. It allows the researchers to control the comparison, rather than comparing results with a study that happened 5 years before with patients that they didn't choose themselves.)
The endpoint for the study was Progression Free Survival -- essentially measuring how long it took for the disease to come back (or for the patient to die). The median PFS for the R-Squared group was 39.4 months (half of patients had an event before that, and half after that, or didn't have an event at all). For the Rituxan group, the PFS was 14.1 months. R-Squared was clearly superior.
While PFS was the main way of measuring the two treatments, there were some other endpoints for the study, and R-Squared was superior in all of them, too. Overall Survival results are "Still maturing," according to the researchers, which is good -- there haven't been enough deaths to say what the halfway point is.
As for safety, there were, of course, side effects. The R-Squared group had more patients with more serious side effects than the Rituxan group. These were already known, and seem typical (lower blood counts, nerve issues, digestive issues). there were two deaths in each group during the trial.
The conclusion to this study: R-Squared will provide another effective alternative for Follicular lymphoma patients who have had previous treatment.
As I said in my earlier post about the FDA review decision, I've been reading about R-Squared for a very long time (almost 10 years), and it's great to see the results of all the excitement that researchers have had about it for all that time.
The approval from the FDA will come sometime in the fall. Seems like chances are good for another arrow in the quiver.
Monday, March 18, 2019
Updated Bendamustine-Rituxan Results
The Journal of Clinical Oncology has published updated results from the BRIGHT study, which compared Bendamustine+ Rituxan to R-CHOP and R-CVP.
In the last few years, B + R has become a popular choice as an immunochemotherapy treatment. It's not the only choice, by any means, but for certain FL patients who need something more aggressive, oncologists are choosing it over R-CHOP or R-CVP. Research has shown that it is as good, or even better, than those other choices, with fewer side effects.
The BRIGHT study has looked at how these treatments match up with each other. It looks specifically at patients who have not had treatment before. The article is an update, looking at how patients have done after 5 years of follow-up.
Results showed that B + R did better than the other two. Progression Free Survival (the time it took for the treatment to stop working) for 5 years was 65.5% for the B + R group and 55.8% for the CHOP/CVP group (the researchers combined the patients who received those two treatments into one group). Duration of response was better for B + R -- in the 5 year period, 26% of B + R patients needed a second treatment, vs. 39% for the other group.
As is often the case with these kinds of comparisons, there was no difference in the Overall Survival between the two groups (81.7% vs 85%). As for side effects, "The overall safety profiles of BR, R-CHOP, and R-CVP were as expected; no new safety data were collected during long-term follow-up." This means that there were fewer side effects for the B + R group. However, there was a higher number of patients who developed another cancer (particularly certain skin cancers).
So what's the significance of all of this for patients?
Well, B + R remains a good choice, and I'm guessing it will remain a popular choice. Many patients seem to use B + R as a first treatment if their FL is on the aggressive side (with some other choices there if it's less aggressive). That will probably continue.
If anything, patients who are using the treatment can probably feel good about the choice.
In the last few years, B + R has become a popular choice as an immunochemotherapy treatment. It's not the only choice, by any means, but for certain FL patients who need something more aggressive, oncologists are choosing it over R-CHOP or R-CVP. Research has shown that it is as good, or even better, than those other choices, with fewer side effects.
The BRIGHT study has looked at how these treatments match up with each other. It looks specifically at patients who have not had treatment before. The article is an update, looking at how patients have done after 5 years of follow-up.
Results showed that B + R did better than the other two. Progression Free Survival (the time it took for the treatment to stop working) for 5 years was 65.5% for the B + R group and 55.8% for the CHOP/CVP group (the researchers combined the patients who received those two treatments into one group). Duration of response was better for B + R -- in the 5 year period, 26% of B + R patients needed a second treatment, vs. 39% for the other group.
As is often the case with these kinds of comparisons, there was no difference in the Overall Survival between the two groups (81.7% vs 85%). As for side effects, "The overall safety profiles of BR, R-CHOP, and R-CVP were as expected; no new safety data were collected during long-term follow-up." This means that there were fewer side effects for the B + R group. However, there was a higher number of patients who developed another cancer (particularly certain skin cancers).
So what's the significance of all of this for patients?
Well, B + R remains a good choice, and I'm guessing it will remain a popular choice. Many patients seem to use B + R as a first treatment if their FL is on the aggressive side (with some other choices there if it's less aggressive). That will probably continue.
If anything, patients who are using the treatment can probably feel good about the choice.
Tuesday, March 12, 2019
CAR-T Hospitalization
Interesting research about the hospitalization of patients who receive CAR-T treatments.
First, a reminder of what CAR-T is, because it has gotten quite a bit of attention in blood cancer circles in the last few years.
CAR-T stands Chimeric Antigen Receptor T-cell therapy. It involves T cells, one of the types of immune cells in the body. T cells are one of the ways the body fights invaders, like bacteria and viruses. But cancer cells are not invaders -- they are part of the body that won't die. So T cells need to be taught to fight them. With CAR-T, some T cells are removed from the patient's body and changed in a lab so they will recognize and fight cancer cells. Then they put back into the body to do their job. One of the great things about the treatment is that T cells have a memory -- if they find an invader that they have already encountered, they will know to fight it again. So if a CAR-T treatment is successful once, it should keep on recognizing and fighting those cancer cells whenever they come back.
As always, if you want to learn more about CAR-T and Follicular Lymphoma, I highly recommend the site CAR-T and Follicular Non-Hodgkin's Lymphoma.
CAR-T also has some potentially bad side effects. When the body fights off and kills huge numbers of cells all at once, it can have a reaction called Cytokine Release Syndrome. This can be severe enough that a few early CAR-T patients died from it. Doctors seem to be better at controlling it now. CAR-T can also cause some neurological problems.
Because of the seriousness of the potential side effects, CAR-T patients often need to stay in the hospital after treatment. That's what two recent studies focused on. Both were published in Biology of Blood and Marrow Transplantation.
One of the two studies deals with very young people (under 25) who have had CAR-T treatment. I'm going to skip that one; it's extremely rare that a young person gets Follicular Lymphoma.
The other study looks at patients who at 18 and over; I think that covers everyone who reads this blog.
The study is called "Emerging Trends in Chimeric Antigen Receptor T-Cell Immunotherapy in Adults from the Vizient Clinical Database."
The study looks at data that is being compiled by Vizient, which tracks information about patients in clinical trials. They tracked 735 patients who had CAR-T between October 2017 and August 2018. For the study, they were interested in what kind of follow-up was needed by the patients. 61.5% of patients has Diffuse Large B Cell Lymphoma. About 4% had Follicular Lymphoma, and the rest had other blood cancers.
They found that the median hospital stay was 15 days, and the media cost of the stay was $82,059. (That's for the hospital stay only -- the treatment itself can cost around $400,000.) During the hosital stay, almost 70% of the patients had a reaction to the treatment, and 12% had other complications. Other side effects: 56% had fever, 55% had a change in blood pressure, 25% had nausea, 18% had headache or migraine, 15% had kidney failure, and 1.5% had in-hospital death. Within 30 days, 16% of patients had to be readmitted to the hospital -- 6% within 7 days.
I find the study interesting for a couple of reasons. First, I see a lot of patients online who get excited about treatments like CAR-T. They should be excited, in some ways. Early results are very good, and should get even better -- my oncologist said CAR-T will be improved in 5 yars as researchers learn more.
But CAR-T isn't a miracle. It works very well for about 1/3 of patients, pretty well (for about a year) in 1/3, and not at all for the other 1/3. Those numbers should get better. But they aren't there yet. And more importantly, as this study reminds us, EVERY cancer treatment has side effects. And some of them are severe. We have to expect some bad with the good.
Second, I find the cost analysis interesting. Vizient is a company that deals with analytics -- they look at data from clinical trials and elsewhere and help their clients deliver "exceptional, cost-effective care." Their job is to help businesses be successful in helping patients, but also do it for the least money possible. I'm not criticizing Vizient. But the study is a reminder that cancer treatment costs money. One of the big criticisms against CAR-T's manufacturers has been the cost of the treatment. The study is a reminder to me that, as treatments get better, cost is going to continue to be a factor. Patients aren't going to be able to bear that cost, so there will need to be some structure in place that helps them. Health care costs are going to continue to be a political problem. If you're looking for an issue to get excited and involved in, that's a good one.
So CAR-T has certainly given us some success. But like every other treatment, we still have a way to go.
First, a reminder of what CAR-T is, because it has gotten quite a bit of attention in blood cancer circles in the last few years.
CAR-T stands Chimeric Antigen Receptor T-cell therapy. It involves T cells, one of the types of immune cells in the body. T cells are one of the ways the body fights invaders, like bacteria and viruses. But cancer cells are not invaders -- they are part of the body that won't die. So T cells need to be taught to fight them. With CAR-T, some T cells are removed from the patient's body and changed in a lab so they will recognize and fight cancer cells. Then they put back into the body to do their job. One of the great things about the treatment is that T cells have a memory -- if they find an invader that they have already encountered, they will know to fight it again. So if a CAR-T treatment is successful once, it should keep on recognizing and fighting those cancer cells whenever they come back.
As always, if you want to learn more about CAR-T and Follicular Lymphoma, I highly recommend the site CAR-T and Follicular Non-Hodgkin's Lymphoma.
CAR-T also has some potentially bad side effects. When the body fights off and kills huge numbers of cells all at once, it can have a reaction called Cytokine Release Syndrome. This can be severe enough that a few early CAR-T patients died from it. Doctors seem to be better at controlling it now. CAR-T can also cause some neurological problems.
Because of the seriousness of the potential side effects, CAR-T patients often need to stay in the hospital after treatment. That's what two recent studies focused on. Both were published in Biology of Blood and Marrow Transplantation.
One of the two studies deals with very young people (under 25) who have had CAR-T treatment. I'm going to skip that one; it's extremely rare that a young person gets Follicular Lymphoma.
The other study looks at patients who at 18 and over; I think that covers everyone who reads this blog.
The study is called "Emerging Trends in Chimeric Antigen Receptor T-Cell Immunotherapy in Adults from the Vizient Clinical Database."
The study looks at data that is being compiled by Vizient, which tracks information about patients in clinical trials. They tracked 735 patients who had CAR-T between October 2017 and August 2018. For the study, they were interested in what kind of follow-up was needed by the patients. 61.5% of patients has Diffuse Large B Cell Lymphoma. About 4% had Follicular Lymphoma, and the rest had other blood cancers.
They found that the median hospital stay was 15 days, and the media cost of the stay was $82,059. (That's for the hospital stay only -- the treatment itself can cost around $400,000.) During the hosital stay, almost 70% of the patients had a reaction to the treatment, and 12% had other complications. Other side effects: 56% had fever, 55% had a change in blood pressure, 25% had nausea, 18% had headache or migraine, 15% had kidney failure, and 1.5% had in-hospital death. Within 30 days, 16% of patients had to be readmitted to the hospital -- 6% within 7 days.
I find the study interesting for a couple of reasons. First, I see a lot of patients online who get excited about treatments like CAR-T. They should be excited, in some ways. Early results are very good, and should get even better -- my oncologist said CAR-T will be improved in 5 yars as researchers learn more.
But CAR-T isn't a miracle. It works very well for about 1/3 of patients, pretty well (for about a year) in 1/3, and not at all for the other 1/3. Those numbers should get better. But they aren't there yet. And more importantly, as this study reminds us, EVERY cancer treatment has side effects. And some of them are severe. We have to expect some bad with the good.
Second, I find the cost analysis interesting. Vizient is a company that deals with analytics -- they look at data from clinical trials and elsewhere and help their clients deliver "exceptional, cost-effective care." Their job is to help businesses be successful in helping patients, but also do it for the least money possible. I'm not criticizing Vizient. But the study is a reminder that cancer treatment costs money. One of the big criticisms against CAR-T's manufacturers has been the cost of the treatment. The study is a reminder to me that, as treatments get better, cost is going to continue to be a factor. Patients aren't going to be able to bear that cost, so there will need to be some structure in place that helps them. Health care costs are going to continue to be a political problem. If you're looking for an issue to get excited and involved in, that's a good one.
So CAR-T has certainly given us some success. But like every other treatment, we still have a way to go.
Thursday, March 7, 2019
Who We Are
I've been thinking a lot about identity lately.
I mean, what it means for us to be cancer patients. How that affects the way we see ourselves, and the ways others see us.
I did a short piece for Blood-Cancer.com called "Not Your Typical Blood Cancer Patient" last week. It's about how different we (blood cancer patients) are, but how much we have in common, too. One of the things I talk about is how "typical" cancer patients are portrayed. I had seen something on Twitter a few months ago. People were using the hashtag #badstockphotosofmyjob. They were searching online for stock photos (those free photos that are supposed to show a generic person or situation) for their jobs. Try it -- search for "Nurse stock photo" or "teacher stock photo" or "cook stock photo" or whatever you do for a living. Sometimes stock photos show people in situations that are a lot nicer than their reality -- teachers don't smile all the time.
So I was really interested in what "cancer patient stock photo" would show me. It was mostly women, almost all either bald (from chemo) or wearing a scarf or covering on their head. And they usually had a really determined look, too, though occasionally, some of them were sad.
Stock photos don't really show the reality, but they're supposed to be common enough that people can recognize them. You know a stock photo of a teacher is a teacher, because that's how we think of teachers.
So is that what people think about when they think of cancer patients? Women, bald (and vulnerable), but determined (and sometimes sad)?
And if that's how they think of us, how does that affect the way they treat us?
And if they treat us a certain way, how does that affect the way we see ourselves?
I saw a post recently on Facebook from a Follicular Lymphoma patient whose mother was acting like she didn't believe that her daughter (an FL patient) had cancer. She sent her an article about people over-reacting to illnesses.
That happens a lot with FL patients -- a lot of us don't look like the stock photos, so we don't have a "real" cancer. And if that's the case -- people don't think we're seriously ill -- then they don't treat us the way they might treat other cancer patients -- with care and compassion.
And that can mess with the way we see ourselves.
My identity -- the way I see myself -- has changed over 11 years. I still call myself a "cancer patient." I've never had a Complete Response on a scan. I still see an oncologist 2 or 3 times a year. I'm a patient.
I also haven't needed treatment in 9 years. That's pretty un-patient-like.
So I struggle sometimes with who I am, and how cancer has made me that person, and how it has changed me. And how much others' perceptions of me have kind of added into the mix.
Maybe "struggled" isn't the right word. "Wrestled"? I think about it a lot.
And I think maybe the important thing about it all is that we make sure that we, the patients, are the ones to decide who we are. Not doctors or family or friends. It has to come with us.
I'm going to continue wrestling with this. I don't know if I'll ever "figure it out," but I'll keep thinking.
I mean, what it means for us to be cancer patients. How that affects the way we see ourselves, and the ways others see us.
I did a short piece for Blood-Cancer.com called "Not Your Typical Blood Cancer Patient" last week. It's about how different we (blood cancer patients) are, but how much we have in common, too. One of the things I talk about is how "typical" cancer patients are portrayed. I had seen something on Twitter a few months ago. People were using the hashtag #badstockphotosofmyjob. They were searching online for stock photos (those free photos that are supposed to show a generic person or situation) for their jobs. Try it -- search for "Nurse stock photo" or "teacher stock photo" or "cook stock photo" or whatever you do for a living. Sometimes stock photos show people in situations that are a lot nicer than their reality -- teachers don't smile all the time.
So I was really interested in what "cancer patient stock photo" would show me. It was mostly women, almost all either bald (from chemo) or wearing a scarf or covering on their head. And they usually had a really determined look, too, though occasionally, some of them were sad.
Stock photos don't really show the reality, but they're supposed to be common enough that people can recognize them. You know a stock photo of a teacher is a teacher, because that's how we think of teachers.
So is that what people think about when they think of cancer patients? Women, bald (and vulnerable), but determined (and sometimes sad)?
And if that's how they think of us, how does that affect the way they treat us?
And if they treat us a certain way, how does that affect the way we see ourselves?
I saw a post recently on Facebook from a Follicular Lymphoma patient whose mother was acting like she didn't believe that her daughter (an FL patient) had cancer. She sent her an article about people over-reacting to illnesses.
That happens a lot with FL patients -- a lot of us don't look like the stock photos, so we don't have a "real" cancer. And if that's the case -- people don't think we're seriously ill -- then they don't treat us the way they might treat other cancer patients -- with care and compassion.
And that can mess with the way we see ourselves.
My identity -- the way I see myself -- has changed over 11 years. I still call myself a "cancer patient." I've never had a Complete Response on a scan. I still see an oncologist 2 or 3 times a year. I'm a patient.
I also haven't needed treatment in 9 years. That's pretty un-patient-like.
So I struggle sometimes with who I am, and how cancer has made me that person, and how it has changed me. And how much others' perceptions of me have kind of added into the mix.
Maybe "struggled" isn't the right word. "Wrestled"? I think about it a lot.
And I think maybe the important thing about it all is that we make sure that we, the patients, are the ones to decide who we are. Not doctors or family or friends. It has to come with us.
I'm going to continue wrestling with this. I don't know if I'll ever "figure it out," but I'll keep thinking.
Sunday, March 3, 2019
FDA Priority Review for R-Squared
The FDA has announced that it will grant Priority Review to R-Squared, the combination of Rituxan and Revlimid (also known as Lenalidomide) for patients with previously treated Follicular Lymphoma.
Priority Review means the FDA will review the application sooner than normal. It should take 6 months, instead of the usual 10 months. Priority Review is granted when the FDA thinks the treatment has the potential for "significant improvements" over current treatments, because it is more effective, or safer, or both.
The application includes data that was presented at the ASH meeting in December. They compared R-Squared to Rituxan in patients that had already had treatment. R-Squared patients had a longer Progression Free Survival (39.4 months, vs. 14.1 months for the Rituxan groups). The R-Squared group also had a higher Overall Response Rate (78% vs. 53%) and a longer duration of response (36.6 months vs. 21.7 months).
It's really strange to see R-Squared finally going up for FDA approval. I've been reading and writing about it for so long, it seems like it should have already been approved. I did a quick search of this blog, and the first time I mentioned Revlimid was in March 2008 -- 11 years ago, just two months after I was diagnosed. Honestly, I didn't think I was even writing about treatments back then. i'm surprised to learn that I've been a Cancer Nerd even longer than I thought. the first time I wrote about the R-Squared combination was in May 2010.
And for almost that long, researchers have been excited about the possibility.
So I'm glad we're finally getting around to an FDA review. That's good.
An interesting side lesson here. It's a good reminder that approvals take a long time. An early trial with good results is something worth being hopeful about, but not too excited about. These things can take years to happen. On the other hand, if something isn't approved right away, that's OK -- as long as good results keep coming, something might be worth the wait.
Priority Review means the FDA will review the application sooner than normal. It should take 6 months, instead of the usual 10 months. Priority Review is granted when the FDA thinks the treatment has the potential for "significant improvements" over current treatments, because it is more effective, or safer, or both.
The application includes data that was presented at the ASH meeting in December. They compared R-Squared to Rituxan in patients that had already had treatment. R-Squared patients had a longer Progression Free Survival (39.4 months, vs. 14.1 months for the Rituxan groups). The R-Squared group also had a higher Overall Response Rate (78% vs. 53%) and a longer duration of response (36.6 months vs. 21.7 months).
It's really strange to see R-Squared finally going up for FDA approval. I've been reading and writing about it for so long, it seems like it should have already been approved. I did a quick search of this blog, and the first time I mentioned Revlimid was in March 2008 -- 11 years ago, just two months after I was diagnosed. Honestly, I didn't think I was even writing about treatments back then. i'm surprised to learn that I've been a Cancer Nerd even longer than I thought. the first time I wrote about the R-Squared combination was in May 2010.
And for almost that long, researchers have been excited about the possibility.
So I'm glad we're finally getting around to an FDA review. That's good.
An interesting side lesson here. It's a good reminder that approvals take a long time. An early trial with good results is something worth being hopeful about, but not too excited about. These things can take years to happen. On the other hand, if something isn't approved right away, that's OK -- as long as good results keep coming, something might be worth the wait.
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