Ahead of ad­comm, FDA rais­es con­cerns about plan to ex­pand Lyn­parza­'s use in prostate can­cer

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee will dis­cuss As­traZeneca and Mer­ck’s ap­pli­ca­tion to ex­pand the use of their drug Lyn­parza to all adults with prostate can­cer on Fri­day, though FDA staff raised con­cerns about the safe­ty and ef­fi­ca­cy da­ta.

The drug com­bo orig­i­nal­ly seemed like an easy ap­proval af­ter the FDA gave it pri­or­i­ty re­view, but the agency de­layed its re­view in De­cem­ber. And in a staff re­port re­leased ahead of the meet­ing, the agency point­ed to a sub­group of pa­tients with­out a BR­CA mu­ta­tion, say­ing that the da­ta the com­pa­nies have sub­mit­ted may not be suf­fi­cient to ex­pand use in that group.

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