FDA Pushes Bristol Myers' Reblozyl Decision Date In Non-Transfusion Dependent Beta Thalassemia

The FDA has extended the review period for Bristol Myers Squibb Co's BMY supplemental application for Reblozyl (luspatercept-aamt) for anemia in adults with non-transfusion-dependent (NTD) beta-thalassemia.

• The agency has pushed the decision to June 27 from March 27, granted earlier under priority review.
• The application was based on results from the pivotal Phase 2 BEYOND study evaluating Reblozyl plus best supportive care.
• An application (Type II variation) is also under review by the European Medicines Agency.
• Reblozyl is currently approved to address transfusion-dependent anemia-associated beta-thalassemia and lower-risk myelodysplastic syndromes failing an erythropoietin-stimulating agent (ESA) and requiring red blood cell transfusions.
• Separately, the Japanese regulatory authority has accepted the supplemental application for Breyanzi (lisocabtagene maraleucel) for the second-line treatment of relapsed or refractory (R/R) large B-cell lymphoma (LBCL).
• Price Action: BMY shares are closed 0.11% higher at $72.50 during after-hours trading on Thursday.