BioPharma Dive April 5, 2024
Abecma is now cleared for adults with relapsed or refractory forms of the blood cancer after two or more prior lines of treatment.
Dive Brief:
- The Food and Drug Administration has cleared Bristol Myers Squibb and 2seventy Bio’s multiple myeloma cell therapy for earlier use treating the blood cancer, approving the CAR-T medicine for patients who have previously received at least two previous drug regimens.
- The OK comes three weeks after a panel of FDA advisers agreed the benefit of earlier treatment outweighed the risks, including a concern raised by agency reviewers over data indicating an elevated risk of death among treated study participants in the first year of the companies’ main trial.
- Overall, trial results showed the CAR-T...
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