Bristol Myers announces FDA approval of label updates for Breyanzi, Abecma

Bristol Myers (BMY) announced that the FDA has approved label updates for both of its CAR T cell therapies, Breyanzi for the treatment of large B cell lymphoma and other lymphomas and Abecma for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy programs that had been in place since each product was initially approved. Across both labels, the FDA has approved the reduction or removal of specific patient monitoring requirements for Breyanzi and Abecma. The changes include: driving restrictions reduced from eight weeks to two weeks post treatment and requirement to stay within proximity of a healthcare facility following infusion reduced from four weeks to two weeks. The FDA has also approved removal of the REMS requirement from each product label.