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).
very interesting, im now fixated with Car T, reading as much as i can, my husband still hasnt received any treatment as of this moment, waiting for biopsy to confirm HT, although petscan shows abdominal node with high suv of 17, no b symptoms, blood work normal, i understand that RCHOP will be the 1st line of treatment if needed. things dont look so bad now with the new Car T
ReplyDeletethanks Bob!
Jeanne
by the way, do you think that Car-T has less toxicity despite CRS than auto/allo sct? and are there studies comparing the 2 treatments with regards to side effects, success/mortality rate etc?
ReplyDeleteJeanne
Jeanne,
ReplyDeleteI don't know of any studies that compare the two. The studies of CAR-T that I have seen are all single studies, looking only at CAR-T. In general, it seems like newer non-chemo options (like CAR-T) still have toxicity, just not the same toxicity. So CRS is a big issue, but it seems like doctors are learning how to deal with it better. No treatment is without side effects; it's a matter of deciding which side effects, long-term and short-term, are more tolerable to the patient, and how they balance with the chance of long-term remission.