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).

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER