FDA hands As­traZeneca and Mer­ck a snap OK to mar­ket Lyn­parza in front­line ovar­i­an can­cer, mark­ing a new stan­dard in treat­ment

As­traZeneca just showed how fast an es­tab­lished can­cer drug can achieve a cru­cial line ex­ten­sion.

Just two months af­ter the phar­ma gi­ant and its part­ners at Mer­ck turned up at ES­MO to tout some tru­ly im­pres­sive de­tailed re­sults for Lyn­parza as a front­line ther­a­py for BR­CA-mu­tat­ed ovar­i­an can­cer, the agency has come through with a snap OK.

The key da­ta point: A haz­ard ra­tio of 0.30, with a pro­found 70% re­duc­tion in risk of death. These days, the FDA is not re­luc­tant to slap an OK on a can­cer drug, and As­traZeneca’s R&D team has spent years work­ing on an ex­pand­ed mar­ket for the drug af­ter win­ning the pi­o­neer­ing ap­proval for a PARP in­hibitor.

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