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FDA Approves BCMA-Directed CAR-T Immunotherapy for R/R MM
On February 28, 2022, a new treatment choice for patients with relapsed or refractory (R/R) multiple myeloma (MM) who received 4 or more previous lines of therapy has been approved by the FDA, according to a news release from The Janssen Pharmaceutical Companies of Johnson & Johnson.
Ciltacabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy that targets B-cell maturation antigen (BCMA) single domain antibodies, achieved deep and durable responses in 98% of patients (95% CI, 92.7-99.7) with R/R MM during the CARTITUDE-1 study, resulting in the approval.
Overall, 78% (95% CI, 68.8-86.1) of patients who achieved this response experienced a stringent complete response (sCR).
At a median follow-up of 18 months, the median duration of response (DOR) was 21.8 months.
The most commonly reported adverse reactions (≥20%) include pyrexia, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, diarrhea, nausea, and fatigue.
Long-term efficacy and safety results of ciltacabtagene autoleucel from the CARTITUDE-1 study are ongoing.—Alexa Stoia
