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Bristol Myers Squibb (BMS) and Bluebird Bio announced on Friday that the FDA has approved its application for BCMA - targeted CAR-T cell therapy Abecma (idecabtagene vicleucel) to treat relapsed or refractory multiple bone marrow Tumor patients.
FDA CAR-T
The therapy is approved as a one-time infusion, and the recommended dose range is 300 to 460 * 10 6 CAR-positive T cells.
6 Immunity
The two companies said this approval is supported by data from the key Phase II KarMMa trial, which evaluated the effectiveness and safety of Abecma (idecabtagene vicleucel) in the treatment of relapsed or refractory multiple myeloma (127 patients) .
The results recently published on NEJM showed that among 100 patients whose efficacy can be evaluated, the overall response rate (ORR) of the Abecma (idecabtagene vicleucel) group was 72%.
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