BMS + Acceleron Pharma provide update on FDA advisory committee for Reblozyl to treat myelodysplastic syndromes.

Bristol-Myers Squibb Company and Acceleron Pharma Inc. announced that following the late-cycle review meeting on 4 December 2019, they were notified by the FDA that Reblozyl (luspatercept-aamt) will not be reviewed at the Oncologic Drugs Advisory Committee (�ODAC�) meeting scheduled for 18 December 2019. The agency has informed Bristol-Myers Squibb that the original Prescription Drug User Fee Act (PDUFA), or target action, date of April 4, 2020 for its supplemental Biologics License Application (�sBLA�) for Reblozyl will remain, without the requirement for an ODAC review.

Bristol-Myers Squibb is seeking approval of Reblozyl, an erythroid maturation agent, representing a new class of therapy, for the treatment of anemia in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who have ring sideroblasts and require red blood cell (RBC) transfusions.