The U.S. Food and Drug Administration (FDA) has approved ABECMA® (idecabtagene vicleucel; ide-cel), from Bristol Myers Squibb and bluebird bio, Inc. ABECMA is the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
ABECMA is the fifth CAR T-cell therapy that the Immunotherapy Program at Northside Hospital Cancer Institute has made available patients. Northside previously announced the additions of BREYANZI™, YESCARTA™, KYMRIAH® and TECARTUS™ immunotherapies.
“ABECMA, the first CAR T against myeloma, provides a much needed option for patients with relapsed refractory MM,” said Dr. Melhem M. Solh, Immunotherapy Program at Northside Hospital Cancer Institute. “Myeloma is considered an incurable disease and patients continue to relapse after all available lines of therapy. With ABECMA, patients with MM that failed all available groups of therapy against their disease, can achieve significant and durable responses.”
Multiple myeloma is a cancer that starts in plasma cells in a patient’s bone marrow and grows out of control to other parts of the body. According to the American Cancer Society, it is a relatively uncommon cancer; about 34,920 new cases will be diagnosed in the United States in 2021. A variety of symptoms can occur in multiple myeloma, most notably low blood counts, bone weakness and increased fractures, infections and kidney problems.
- In the study, the overall response rate (ORR) for the efficacy evaluable population (n=100) was 72% (95% CI: 62-81), and 28% of patients achieved a stringent complete response (sCR; 95% CI: 19-38).
- Responses were rapid and durable, with a median time to response of 30 days (range: 15 to 88 days) and median duration of response of 11 months (95% CI: 10.3 – 11.4) for all responders and 19 months (95% CI: 11.4 – NE) for those who achieved sCR.
- Of the 28 patients who achieved sCR, an estimated 65% (95% CI: 42% - 81%) had remission lasting at least 12 months.
To make a CAR T-cell referral, or to speak with a physician, please call 404-255-1930.
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