FDA Delays Decision on Bristol Myers and 2seventy Bio's CAR-T Therapy

The FDA has delayed 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. The regulator plans to hold a public meeting with outside experts to discuss the therapy, which was originally expected to receive a decision by December 16. Currently, the therapy is approved for multiple myeloma patients who have previously had four or more lines of treatment.