Abecma, a personalized CAR T cell therapy, has received expanded approval from the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma. This new indication allows for earlier use of Abecma after two or more prior lines of therapy, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.
In the Phase 3 KarMMa-3 trial, Abecma tripled progression-free survival compared to standard regimens. Patients receiving Abecma experienced a 51% reduction in the risk of disease progression or death. These results demonstrate the significant clinical benefit of Abecma in this patient population.
Abecma is administered as a one-time infusion, with a recommended dose range of 300 to 510 x 106 CAR-positive T cells. It is designed to target and eliminate multiple myeloma cells more effectively than traditional therapies.
Abecma is now approved in the U.S., Japan, Switzerland, and the EU for the treatment of relapsed or refractory multiple myeloma in earlier lines of therapy. Bristol Myers Squibb and 2seventy bio are committed to expanding access to Abecma globally.
This expanded approval provides a valuable new treatment option for patients with relapsed or refractory multiple myeloma. Abecma offers the potential for longer periods of remission and reduced disease progression, offering hope for improved outcomes in this challenging disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
