BMS’ Abecma (Idecabtagene Vicleucel) Receives EC’s Conditional Approval for Relapsed and Refractory Multiple Myeloma

 BMS’ Abecma (Idecabtagene Vicleucel) Receives EC’s Conditional Approval for Relapsed and Refractory Multiple Myeloma

BMS’ Abecma (Idecabtagene Vicleucel) Receives EC’s Conditional Approval for Relapsed and Refractory Multiple Myeloma

Shots:

  • The conditional approval is based on KarMMa study evaluating Abecma (single infusion with a target dose of 420 x 10^6 CAR T cells over a range of 260 to 500 x 10^6 CAR-positive viable T cells) in 128 patients with r/r MM prior treated with 3L therapies including an immunomodulatory agent, a proteasome inhibitor & an anti-CD38 Ab and who are refractory to their last treatment
  • Results: ORR (73%); CR rate (33%) & median time to response (1mos.)., m-DoR (10.6mos. & 23 mos. who achieved a CR), responses were rapid & durable with a well-established safety profile
  • The company will expand its manufacturing capability of Abecma globally including Leiden & Netherlands. Abecma is a BCMA CAR T cell immunotherapy for adults with MM

Click here to­ read the full press release/ article | Ref: BMS | Image: Fierce Biotech