FDA Waives ODAC Review of Luspatercept in MDS

December 6, 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. The companies noted in a press release that the … (leggi tutto)