BRIEF—No advisory committee review of B-MS' Reblozyl to be required

The US Food and Drug Administration has said that Bristol-Myers Squibb’s Reblozyl (luspatercept-aamt) will not be reviewed at the Oncologic Drugs Advisory Committee (ODAC) meeting scheduled for December 18, 2019.

The agency has informed B-MS 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.

The company 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.

Reblozyl is already FDA-approved for the treatment of anemia in adult patients with beta thalassemia who require regular RBC transfusions. Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. The drug is not approved for the treatment of MDS in any country.