News from Friday: The makers of the CAR-T treatment Yescarta have applied for approval from the FDA for Relapsed and Refractory Indolent Lymphomas, including Follicular Lymphoma.
This is a big deal.
There's been a lot going on in the news in the last few months about CAR-T for R/R FL, so let's sort it all out.
There have been two CAR-T treatments approved by the FDA for aggressive lymphomas, including transformed FL. They are called Yescarta and Kymriah.
While the approvals are for aggressive FL, they don't cover the kind of slower-growing FL that most of us are experiencing. But there are trials involving both Yescarta and Kymriah for R/R FL -- patients who have had treatment that either stopped working, or never worked at all.
A few weeks ago, the makers of Kymriah announced that their phase 2 for R/R FL trial was going very well. They didn't release any numbers, but promised to present them at upcoming conferences (probably the ASH conference in December). The FDA had already given them Regenerative Medicine Advanced Therapy Designation for R/R FL, meaning they were on rack to seek approval. But that hasn't happened yet.
Instead, Yescarta beat them to it. The phase 2 ZUMA-5 trial, which involves giving CAR-T to R/R FL patients, has really good results: a 95% Overall Response Rate, with a 81% Complete Response Rate. that's pretty great.
The usual caveats apply -- phase 2 is a small study (96 patients overall). The median PFS was just under 2 years. Those are both higher than the earlier trials that led to the first approval, which is very encouraging.
Then there's the cost of CAR-T. Since it's made specially for each patient, it can cost close to $500,000 per treatment. That's not a lot if it's the last treatment a patient needs, compared to how much all of the other treatments might cost.
And I have seen some FL patients online who have been very big fans of CAR-T, and who are saying this is going to be The Cure.
I'm thinking....maybe some day. But not yet. Researchers are learning more and more about how to make CAR-T treatments more effective and safer, and these results would back that up. But it's still too early to say for sure.
In the meantime, we can be excited that another potential treatment is another step closer to being available for a larger number of people. I'm looking forward to hearing more about both types of CAR-T for R/R FL, and how realistic it might be for them to be available to lots of FL patients.
Update: And remember, for more on CAR-T and Follicular Lymphoma, visit Ben and William's site CAR-T and Follicular Non-Hodgkin's Lymphoma.
Hi Bob
ReplyDeletePlease remind your readers again that Ben and I maintain a website for FL patients who have had or are considering CAR-T: https://fnhlben.wordpress.com/
Thanks & stay safe,
William
Done!
ReplyDelete