Eli Lil­ly bags FDA nod for Verzenio in ear­ly breast can­cer, but a con­tro­ver­sial di­ag­nos­tic could dog its roll­out

As Eli Lil­ly works to con­sol­i­date its in­ter­nal and Loxo teams in­to an on­col­o­gy pow­er­house, the drug gi­ant is putting high hopes on CDK 4/6 in­hibitor Verzenio to help dri­ve the port­fo­lio in­to the fu­ture. Now, the drug has scored a par­a­digm-al­ter­ing win in ear­ly breast can­cer — but will a con­tro­ver­sial com­pan­ion di­ag­nos­tic ham­string Lil­ly’s mar­ket plans?

The FDA on Wednes­day ap­proved CDK 4/6 in­hibitor Verzenio in com­bi­na­tion with physi­cian’s-choice en­docrine ther­a­py to cut the risk of re­lapse in pa­tients with high-risk HR-pos­i­tive, HER2-neg­a­tive breast can­cer, Lil­ly said in a re­lease.

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