Bristol Myers wins favorable FDA label updates for cell therapies Breyanzi and Abecma

Bristol Myers Squibb (NYSE:BMY) announced that the U.S. FDA has approved several label updates for its cancer therapies, Breyanzi and Abecma, which could help the company widen access to the two CAR-T cell therapies.

The updates are related to the use of Breyanzi in lymphomas, including large B-cell lymphoma, and the use of Abecma in multiple myeloma.

Specifically, as part of the label changes, the FDA has relaxed certain patient monitoring requirements and removed REMS (Risk Evaluation and Mitigation Strategy) programs required to administer the drugs.

“Today’s FDA-approved label updates reinforce BMS’ continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy,” said Lynelle Hoch, BMY’s president of Cell Therapy Organization.

Following the approval, Bristol Myers (NYSE:BMY) plans to remove the REMS programs implemented across more than 150 treatment centers allowed to administer Breyanzi and Abecma.

The company also intends to rapidly expand the network of community cancer centers nationwide that can administer Breyanzi and Abecma in a bid to cut patients’ travel time to receive the therapies.