Biopharmaceutical company Bristol Myers Squibb (NYSE:BMY) announced late Thursday that the US Food and Drug Administration has approved updated labels for its two CAR T cell therapies, reducing patient monitoring requirements and removing Risk Evaluation and Mitigation Strategy (REMS) programs.

These changes apply to Breyanzi (lisocabtagene maraleucel; liso-cel) for large B cell lymphoma and other lymphomas, and Abecma (idecabtagene vicleucel; ide-cel) for multiple myeloma. The updates include shortening driving restrictions from eight to two weeks post-infusion and reducing proximity-to-care requirements from four to two weeks.

The FDA's decision reflects increasing confidence in the safety of CD19- and BCMA-directed autologous CAR T cell therapies, supported by extensive clinical and real-world evidence. Over 30,000 patients have been treated with CAR T therapies, with most serious side effects occurring within the first two weeks of treatment.

Eliminating the Risk Evaluation and Mitigation Strategy (REMS) programmes acknowledges the oncology community's ability to manage risks like cytokine release syndrome and neurologic toxicities without additional regulatory oversight.

Bristol Myers Squibb aims to expand access to these therapies by increasing the number of treatment centres and enabling administration in community cancer centres.

Currently, only about 20% of eligible patients receive cell therapy due to logistical and geographic barriers. These label changes are expected to reduce such barriers and support broader, more equitable access.