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.

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