– Calling it “a win for patients,” the International Myeloma Foundation (IMF) welcomed the FDA approval on March 26 of Abecma (idecabtagene vicleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy.
“The FDA’s approval means that myeloma patients have gained yet one more treatment option for this cancer of the blood plasma cells,” said Dr. Durie, Chairman of the IMF, a patient advocacy and research non-profit whose reach extends to more than 525,000 people in 140 countries worldwide.
Abecma, a personalized immune cell therapy delivered as a one-time infusion, is approved for use in adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
FDA approval was based on the results of the phase II KarMMa clinical trial in patients with relapsed and refractory myeloma. Patients in the trial were treated with T cells (autologous, meaning their own) engineered to target B-cell maturation antigen (BCMA) on the surface of the myeloma. Of 140 patients enrolled, 128 received treatment.
“Overall, the results of the trial were extremely promising, with a median response duration of 10.7 months, progression-free survival (PFS) of 8.8 months and overall survival of 19.4 months,” Dr. Durie reported at the time of the study’s publication in NEJM. “Patients achieving a complete response or better had a longer response duration of 19 months.”
One-third of patients in the clinical trial achieved meaningful responses in the one-to-two-year range or better, resulting in “an excellent quality of life period of time off from any type of conventional anti-myeloma therapy.”
About the International Myeloma Foundation
Founded in 1990, the International Myeloma Foundation (IMF) is the first and largest foundation focusing specifically on multiple myeloma. The Foundation’s reach extends to more than 525,000 members in 140 countries worldwide. The IMF is dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure by focusing on four key areas: research, education, support, and advocacy. The IMF has conducted more than 250 educational seminars worldwide, maintains a world-renowned InfoLine, and in 2001, established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. In 2012, the IMF launched the Black Swan Research Initiative®, a groundbreaking research project aimed at curing myeloma. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org. Follow the IMF on Twitter @IMFmyeloma.
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SOURCE International Myeloma Foundation