FDA approves Pfizer's Besponsa for ALL

FDA approved a BLA from Pfizer Inc. (NYSE:PFE) for Besponsa inotuzumab ozogamicin to treat adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia.

Besponsa’s label includes a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease (VOD) and increased risk of post-hematopoietic stem cell transplant (HSCT) non-relapse mortality...