FDA rais­es ques­tions in ad­comm brief­ing docs for Roche's Po­livy la­bel ex­pan­sion

An FDA ad­vi­so­ry com­mit­tee is meet­ing on Thurs­day to weigh a po­ten­tial la­bel ex­pan­sion for Roche’s po­ten­tial block­buster Po­livy, but the agency has some con­cerns about ef­fi­ca­cy and safe­ty.

The phar­ma gi­ant will come be­fore the On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee (ODAC) on Thurs­day to dis­cuss da­ta from the Phase III Po­lar­ix tri­al, orig­i­nal­ly in­tend­ed to meet a post-mar­ket­ing re­quire­ment, and see if Po­livy can be used for pa­tients with ear­li­er lines of dif­fuse large B-cell lym­phoma (DL­B­CL).

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