Pfiz­er, Astel­las win pri­or­i­ty re­view for Xtan­di sN­DA; Hemi­spherx changes its name

→ The FDA has grant­ed Pfiz­er $PFE and Astel­las pri­or­i­ty re­view for a la­bel ex­pan­sion for Xtan­di, the prostate can­cer drug it grabbed in the $14 bil­lion ac­qui­si­tion of Medi­va­tion. An ap­proval here, for metasta­t­ic hor­mone-sen­si­tive prostate can­cer, would make the drug avail­able to pa­tients ear­li­er in their treat­ment reg­i­men, the com­pa­nies said. In two Phase III stud­ies, the drug was shown to im­prove pro­gres­sion-free sur­vival when used in con­junc­tion with an­dro­gen de­pri­va­tion ther­a­py. 

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