Another CAR-T Approval

More FDA approval news that is meaningful for Follicular Lymphoma patients.

Last week, the FDA approved the CAR-T called Breyanzi (also known as Lisocabtagene Maraleucel) for certain types of aggressive B Cell Lymphomas, including grade 3b Follicular Lymphoma, as well as Transformed Follicular Lymphoma. The approval includes only patients whose disease is refractory or relapsed after at least two previous treatments (that is, those treatments didn't work, or did work but then stopped working). 

The grade 3b FL approval is kind of a big deal. Grade 3b is an unusual variation of FL. It is still officially Follicular Lymphoma, and hasn't transformed to another lymphoma, but is more aggressive than grade 3a, and acts like a more aggressive lymphoma like Diffuse Large B Cell Lymphoma. It isn't usually grouped with more aggressive lymphomas, but it isn't like slow-growing indolent lymphomas, so patients with grade 3b can be in a sort of limbo sometimes. So it's great that they are being included in this group.

 I won't get into what CAR-T is too much, other than to say it involves removing some T cells (a type of immune cell) from the patient, manipulating them in a laboratory so they recognize cancer cells as something that the immune system should go after, and then returning them back into the patient's body. Early CAR-T treatments showed a lot of promise, and they seem to be getting better all the time. If you want to know more about CAR-T and Follicular Lymphoma, I recommend this site. 

The approval means that there are now four different CAR-Ts approved for blood cancer, with three of them being available for some Follicular Lymphoma patients.  While the approvals are for more aggressive versions of FL, there are very promising results recently for CAR-T for slower-growing FL, and for first treatments (rather than for relapsed and refractory disease only). I'm sure we will hear more about them in a few months at the ASCO conference. I hope it turns out to be one of the big stories that gets talked about by experts.

Of course, as promising as CAR-T is, it has its share of side effects, some of them potentially serious. The FDA approval for Breyanzi was based on a clinical trial involving 192 patients. The Overall Response Rate was 73%, including 54% Complete Response and 19% Partial Response. The median duration of response for 16.7 months, but for those with a Complete Response, the media hasn't been reached yet (which is good  -- more than half have not had the disease return yet). 

But then there are the side effects. Almost half of patients had Cytokine Release Syndrome of some kind (an immune response that can be fatal, as it was for one of the patients in the trial). There were also nerve-related side effects (some very serious) and  blood count issues. Almost half of patients had what were considered "serious" side effects of some kind.

Still, despite the side effects, the treatment was approved, which suggests that the side effects maybe have become more manageable over time.

As a press release from the Leukemia and Lymphoma Society puts it, this approval "further solidifies immunotherapy as a mainstay in cancer treatment." As researchers are finding new ways to use our immune systems to control and beat cancer, we'll certainly see more treatments come our way.

Yet more to be hopeful about.