FDA Ad Com set for Bristol-Myers' luspatercept for MDS

Dec. 03, 2019 9:36 AM ETBristol-Myers Squibb Company (BMY), MRKBy: Douglas W. House, SA News Editor6 Comments
  • The FDA's Oncologic Drugs Advisory Committee will meet on Wednesday, December 18, to review and discuss Bristol-Myers Squibb's (NYSE:BMY -0.4%) supplemental marketing application seeking approval to use Reblozyl (luspatercept-aamt) to treat patients with myelodysplastic syndromes (MDS), specifically those with very low-to-intermediate-risk MDS-associated anemia who have ring sideroblasts and require red blood cell transfusions.
  • The FDA approved the erythroid maturation agent last month for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions.
  • The company is co-developing the med with Acceleron Pharma (XLRN -0.7%).

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