De­spite ques­tion­able PARP da­ta, FDA stamps quick OK on Lyn­parza as a front­line ther­a­py for pan­cre­at­ic can­cer

FDA an­a­lysts picked apart the da­ta, high­light­ed an ab­sence of over­all sur­vival ben­e­fit and not­ed that As­traZeneca had yet to hit the mark re­quired for ear­li­er pan­cre­at­ic can­cer drug ap­provals — but it didn’t make any dif­fer­ence in the end. Short­ly af­ter a slight ma­jor­i­ty of ex­pert ad­vis­ers vot­ed 7 to 5 in fa­vor of us­ing Lyn­parza as a main­te­nance ther­a­py for germline BR­CA-mu­tat­ed metasta­t­ic ade­no­car­ci­no­ma of the pan­creas af­ter 16 weeks of dor­man­cy, the FDA fol­lowed up with a for­mal sanc­tion of its own on Mon­day.

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