Yet Another CAR-T Approval for Follicular Lymphoma

Big news for a lot of Follicular Lymphoma patients: The FDA approved a version of CAR-T for patients with Relapsed or Refractory disease and who have had at least two prior treatments.

The news was announced a few days ago, and I've seen a bunch of stories about it -- it's a big deal. I'm finally getting a chance to write about it.

There have already been a few versions of CAR-T approved for more aggressive lymphomas, including transformed FL and grade 3b FL. This approval (for the CAR-T known as Yescarta, or axicabtagene ciloleucel) is approved for indolent (slower-growing) FL. This expands the number of FL patients eligible for CAR-T by a large number.

The approval came from data from the ZUMA-5 trial. It's a phase 2 clinical trial, so it's an Accelerated Approval.  As I wrote about a couple of weeks ago, the numbers for the trial have been impressive. The Response Rate was 91% for patients with Relapsed or Refractory FL (their last treatment stopped working, or didn't work at all). An earlier article I linked to a few weeks ago said that 80% of FL patients had a Complete Response. After 18 months, 74% of patients with a Complete Response were still in remission.

So, in short, it works, and it continues working for a while.

As with any treatment, serious (even life-threatening) side effects are inevitable, and CAR-T is no different. In this study, 8% of patients had serious Cytokine Release Syndrome, and 21% had severe problems with nerve damage. Many patients experienced less severe side effects as well.

This is all great news. I know many readers are in a position where they've had a couple of treatments already and this is the group who would be eligible for this CAR-T treatment.

Of course, the issue that comes up is cost. Because CAR-T is created by removing T cells from each individual patient and manipulating them in a lab before putting them back into the patient, the process of creating CAR-T is fairly time- and labor-intensive. A single treatment can cost almost a half million dollars. 

The hope is that, with more patients eligible, maybe the manufacturing process will change to become more efficient and less costly. We shall see.

For now, this is cause to celebrate. Another arrow in the quiver for a lot of Follicular Lymphoma patients.