Breyzani Approved For CLL/SLL and FDA Advisory Committee Votes in Favor of Abecma for MM

Last week was an eventful one for Bristol Myers Squibb. On Thursday, BMS announced that the FDA has granted accelerated approval of Breyanzi (lisocabtagene maraleucel). With this approval, Breyanzi becomes the first and only CAR-T cell therapy for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

On Friday, March 15, BMS announced that the FDA Oncologic Drugs Advisory Committee (ODAC) has voted in favor of BMS’s and 2seventy bio's Abecma (idecabtagene vicleucel) for patients with relapsed or refractory multiple myeloma in earlier lines of therapy. The favorable recommendation ODAC will be considered as part of the FDA’s review of Abecma’s supplemental biologics license application for such patients.

Breyzani approved for CLL/SLL

Breyzani is a CD19-directed CAR-T cell therapy and was initially approved in 2021 for adults with relapsed or refractory large B-cell lymphoma. CAR-T cell therapy involves modifying a patient's own immune cells to recognize and attack cancer cells.

CLL and SLL are B-cell malignancies that are commonly treated with targeted therapies, but patients may experience relapse or become refractory.

Breyanzi has shown promising results in phase 1-2 TRANSCEND CLL 004 clinical trials, demonstrating high response rates and durable remissions in patients with CLL or SLL. The latest approval may offer new hope for patients who haven’t responded to targeted therapies, such as Bruton tyrosine kinase inhibitors like Imbruvica (ibrutinib) and B-cell lymphoma 2 inhibitors like Venclexta (venetoclax).

FDA Advisory Committee Votes in Favor of Abecma for MM

The FDA's ODAC has voted in favor of BMS’ and 2seventy bio's Abecma for patients with triple-class exposed relapsed or refractory multiple myeloma in earlier lines of therapy.

Patients with triple-class-exposed multiple myeloma have been treated with at least one immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. There is currently no standard treatment for these patients, and new therapies are in high demand.

Abecma, another CAR-T cell therapy, is designed to target and bind to the B-cell maturation antigen (BCMA) on multiple myeloma cells, causing CAR-T cell proliferation, cytokine release, and subsequent killing of BCMA-expressing cells. It was initially approved in 2021 as the first therapy of its kind for adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy.

The favorable vote was based on promising findings from the phase 3 KarMMa-3 study, including the key secondary endpoint of overall survival. Abecma, if approved, will offer a new treatment option for patients with triple-class exposed multiple myeloma in earlier lines of therapy, addressing an unmet need.