FDA shoves Bay­er’s lym­phoma drug co­pan­lis­ib in­to the spot­light with its promise of a speedy re­view

Bay­er is get­ting VIP treat­ment at the FDA for its mid-stage lym­phoma drug co­pan­lis­ib. Reg­u­la­tors agreed to give the drug a pri­or­i­ty re­view — lop­ping 4 months off the stan­dard 10 month cy­cle — and height­en­ing its chances for a quick OK.

The PI3K drug — an IV ther­a­py tar­get­ing PI3K-αl­pha and delta — first gained some at­ten­tion in late March when in­ves­ti­ga­tors re­port­ed that the treat­ment scored pos­i­tive da­ta for in­do­lent non-Hodgkin lym­phoma.

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