FDA Set to Approve Earlier Use of CAR T for Multiple Myeloma

Multiple myeloma is cancer of the plasma cells that originates in bone marrow. In 2021 and 2022, the Food and Drug Administration approved two chimeric antigen receptor T-cell (CAR T) therapies for multiple myeloma patients that target a specific protein found on myeloma cells.

CAR T uses a patient’s own immune system to find and destroy cancer cells. It involves genetically modifying T cells to bind to specific proteins on cancer cells and then reintroducing those cells into a patient’s blood to attack the cancer.

Currently, the two treatments are approved for multiple myeloma patients who have failed four lines of treatment. The FDA is now reviewing expanded approval for earlier use for multiple myeloma.

We’re really excited about this approval because we know that it’s already working so well for people who’ve seen so much treatment. We think that with people whose immune system hasn’t been exposed to that much chemo, that it would work even better.

Dr. Brandon Blue, Department of Malignant Hematology

“We saw the therapy has worked so well, but what about the people who’ve only seen one, two or maybe even three lines of treatment? Will it work even better?” said Dr. Brandon Blue, a hematologist at Moffitt Cancer Center. “So, we’re really excited about this approval because we know that it’s already working so well for people who’ve seen so much treatment. We think that with people whose immune system hasn’t been exposed to that much chemo, that it would work even better.”

The FDA will decide on whether to approve the CAR T therapy Abecma as a second-line treatment and the CAR T therapy Carvykti as a third-line treatment. The two therapies have very subtle differences, but both target the B-cell maturation antigen protein found on myeloma cells. Both versions of the therapy have proved to be effective.

A decision is expected in April or May.

“This is really going to change the landscape of this disease because right now it’s only restricted for those few people who have unfortunately relapsed multiple lines, but now it will be seen much, much earlier,” Blue said.

A potential upcoming @US_FDA approval will give #MultipleMyeloma patients earlier access to two different CAR T cell therapies. Currently, the two cellular immunotherapies are only available after patients have failed four or more lines of therapy. If approved, patients could… pic.twitter.com/IcQ55Vtfq5

— Moffitt Cancer Center (@MoffittNews) March 28, 2024