BMS and bluebird bio’s Abecma (idecabtagene vicleucel) Receive the US FDA’s Approval as the First Anti-BCMA CAR T Cell Therapy for R/R Multiple Myeloma

March 29, 2021 Auto Bot Abecma, approval, bluebird bio, BMS, FDA, multiple myeloma, Receive, regulatory 0

Shots:

  • The approval is based on the P-II  KarMMa trial that involves assessing Abecma in 127 patients with r/r MM prior treated with 3L+ therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab
  • Results: ORR (72%); sCR (28%); mDoR (11mos.); responses were rapid and durable, with a median time to response of 30 days (range: 15-88 days). The safety profile of Abecma is well-established and predictable including cytokine release syndrome and neurologic toxicities that are mostly low-grade with early-onset and resolution
  • Abecma is a personalized immune cell therapy approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: StraitTimes

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