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FDA Waives ODAC Review of Luspatercept in MDS

Jason M. Broderick @jasoncology
Published: Friday, Dec 06, 2019

The FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting on December 18, 2019, will no longer include a session reviewing a supplemental Biologics License Application (sBLA) for luspatercept-aamt (Reblozyl) for use as a treatment for patients with myelodysplastic syndromes (MDS), according to Bristol-Myers Squibb and Acceleron Pharma, the codevelopers of the erythroid maturation agent.1

 in November 2019 for the treatment of anemia in adult patients with beta thalassemia who require regular RBC transfusions.

References

  1. Bristol-Myers Squibb and Acceleron Pharma Provide Update on FDA Advisory Committee for Reblozyl® (luspatercept-aamt). BMS. Published December 6, 2019. https://bit.ly/34SCgEh. Accessed December 6, 2019.
  2. Fenaux P, Platzbecker U, Mufti GJ, et al. The MEDALIST Trial: results of a phase 3, randomized, double-blind, placebo-controlled study of luspatercept to treat anemia in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts (RS) who require red blood cell (RBC) transfusion. Blood. 2018;132:1. doi: 10.1182/blood-2018-99-110805.

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