BMS
FDA Warns of T-Cell Malignancy Risk Following Autologous CAR T-Cell Therapy
Although the agency said the benefits of these treatments still outweigh their risks, it is investigating the potential for serious adverse outcomes and assessing the need for regulatory action.
FDA Puts Abecma Application on Hold to Allow Advisory Committee Data Review
The agency will not make a decision on BMS and 2seventy Bio's application for Abecma in earlier stage multiple myeloma by the original December deadline.
FDA Approves BMS's Augtyro for Advanced ROS1-Positive NSCLC
The approval is based on results from the Phase I/II TRIDENT-1 clinical trial of Augtyro in both TKI-pretreated and TKI-naïve ROS1-positive NSCLC.
FDA Accepts BMS's sBLA for Breyanzi in Certain Leukemias, Lymphomas
BMS is seeking to expand Breyanzi's indication to include chronic lymphocytic leukemia and small lymphocytic lymphoma patients.
Executives noted that its two recent acquisitions, Mirati Therapeutics and Turning Point Therapeutics, underscore its shift away from immunotherapy.