FDA Panel to Review Application for Luspatercept in MDS

December 3, 2019 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) has scheduled a hearing for December 18, 2019, to review a supplemental Biologics License Application (sBLA) for luspatercept-aamt for use as a treatment for patients with myelodysplastic syndromes (MDS). The sBLA for luspatercept is specifically for patients with very low- to intermediate-risk MDS-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions … (leggi tutto)