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.

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