FDA will convene adcomm for Bristol-Myers' Reblozyl in MDS; FDA grants 'orphan' tags to a trio of drugs
→ Celgene and Acceleron‘s Reblozyl (luspatercept) earned an OK from the FDA last month to treat anemia in adults who require regular transfusions, but still had a pending review with regulators about using the drug for myelodysplastic syndromes (MDS). Now, Bristol-Myers — which finally completed its $74 billion takeover of Celgene — and Acceleron said the FDA’s Oncologic Drugs Advisory Committee will meet later this month to discuss their supplemental biologics license application to to cover the treatment of adult patients with very low- to intermediate-risk MDS-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions. The PDUFA date is set for April 4, 2020.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.