Bristol Myers Squibb Receives European Commission Approval for Idecabtagene Vicleucel, the First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma
Idecabtagene Vicleucel represents the only cell therapy approved for multiple myeloma
Approval of Idecabtagene Vicleucel is based on the pivotal KarMMa trial of patients worldwide, including five European countries, which demonstrated rapid, deep and durable responses with a well-understood and predictable safety profile
Idecabtagene Vicleucel expands upon Bristol Myers Squibb’s leadership in cell therapy research and multiple myeloma, offering an innovative option to patients in need.
Idecabtagene Vicleucel (ide-cel), a first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Idecabtagene Vicleucel is the first and only CAR T cell therapy approved that is directed to recognize and bind to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.1 Idecabtagene Vicleucel is delivered via a single infusion with a target dose of 420 x 106 CAR-positive viable T cells within a range of 260 to 500 x 106 CAR-positive viable T cells. Idecabtagene Vicleucel is approved for use in all European Union (EU) member states.
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