Bristol Myers Squibb’s Reblozyl, chasing $4B sales target, wins key FDA label expansion

Thanks to a new FDA approval, Bristol’s Reblozyl can be used as a first-line treatment for anemia in patients with very low- to intermediate-risk myelodysplastic syndromes who haven’t received a prior erythropoiesis stimulating agent (ESA). The new nod also covers patients regardless of ring sideroblast status.

The FDA based the approval on results from the pivotal phase 3 COMMANDS trial. In the study, Reblozyl outperformed ESAs in this patient population, becoming the first drug ever to do so.

In the study, 58.5% of patients on Reblozyl...