FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS
The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking to expand the current indication of luspatercept-aamt (Reblozyl) to include treatment of anemia in patients with very low- to intermediate-risk MDS who have not previously received erythropoiesis-stimulating agents (ESAs) and may require red blood cell (RBC) transfusions. Furthermore, the European Medicines Agency (EMA) has validated luspatercept's type II variation application in the same indication.
Data from the phase III COMMANDS trial (NCT03682536) showed that luspa...
