Mer­ck to with­draw dan­gling ac­cel­er­at­ed ap­proval for Keytru­da in third-line stom­ach can­cer

In a first for the dan­gling ac­cel­er­at­ed ap­provals re­viewed by FDA’s on­col­o­gy ad­comm in April, Mer­ck on Thurs­day af­ter­noon agreed to pull a third-line stom­ach can­cer in­di­ca­tion for its block­buster Keytru­da af­ter late-stage con­fir­ma­to­ry tri­als failed to show clin­i­cal ben­e­fit.

This in­di­ca­tion was just one of two (out of six to­tal votes) neg­a­tive votes from the out­side ex­perts at the meet­ing. ODAC vot­ed 6-2 against keep­ing Keytru­da as a third-line treat­ment for stom­ach can­cer, and pan­elists point­ed to the chang­ing treat­ment land­scape as ear­li­er in April, an­oth­er check­point in­hibitor, Bris­tol My­ers Squibb’s Op­di­vo, won full ap­proval from the FDA and showed pos­i­tive over­all sur­vival ben­e­fit as a first-line treat­ment for stom­ach can­cer.

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