Bris­tol My­ers gets pri­or­i­ty re­view for first-line Re­blozyl; Two star­tups clinch new cash

Bris­tol My­ers Squibb is on the cusp of a new FDA de­ci­sion. And it could come in the first-line set­ting.

The NJ-based Big Phar­ma said Mon­day that US reg­u­la­tors ac­cept­ed a sup­ple­men­tal NDA for Re­blozyl, al­so known as lus­pa­ter­cept, to treat ane­mia in adults with “very low- to in­ter­me­di­ate-risk” myelodys­plas­tic syn­dromes, who might need red blood cell trans­fu­sions. Pa­tients must al­so not have pre­vi­ous­ly re­ceived ery­thro­poiesis-stim­u­lat­ing agents, or ESAs.

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