Tech glitch­es over­shad­ow FDA on­col­o­gy ad­comm as a sol­id ma­jor­i­ty of ad­vis­ers vote to keep Roche's Tecen­triq in mTNBC

Kick­ing off three days of re­ex­am­in­ing an­ti-PD(L)-1 ac­cel­er­at­ed ap­provals, the FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee start­ed slow­ly on Tues­day. Af­ter a more than hour-long tech­ni­cal de­lay, mem­bers vot­ed 7-2 to keep alive the ac­cel­er­at­ed ap­proval for Genen­tech’s Tecen­triq (ate­zolizum­ab) plus Abrax­ane (nab-pa­cli­tax­el) in metasta­t­ic triple neg­a­tive breast can­cer (mTNBC) while ad­di­tion­al con­fir­ma­to­ry tri­als are on­go­ing.

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