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

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

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  • 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

 Ref: BMS | Image: BMS

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