Bristol Myers and 2seventy bio say FDA delayed CAR-T therapy decision
The FDA is delaying its decision on whether to approve Bristol Myers Squibb and 2seventy bio’s CAR-T cell therapy for multiple myeloma in earlier lines of treatment, and it plans to hold a public meeting with outside experts to discuss.
The regulator was originally expected to make a decision by Dec. 16 on whether to approve Abecma for multiple myeloma in adults whose cancer returned after already receiving two to four prior regimens. Currently, the drug is approved for multiple myeloma patients who have previously had four or more lines of treatment.
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