Bris­tol My­ers Squibb walks on Op­di­vo's FDA nod for small-cell lung can­cer af­ter mid­dling OS da­ta could­n't back ap­proval

In a pitched bat­tle against Mer­ck’s Keytru­da, Bris­tol My­ers Squibb’s im­munother­a­py head­lin­er Op­di­vo land­ed a ma­jor sal­vo with a ground­break­ing FDA ap­proval for cer­tain lung can­cer pa­tients back in 2018. Since that nod, how­ev­er, Op­di­vo has turned out clin­i­cal duds in that mar­ket, and now Bris­tol is cut­ting its loss­es.

Bris­tol has agreed to give up Op­di­vo’s third-line-or-lat­er FDA ap­proval for small-cell lung can­cer af­ter con­fir­ma­to­ry tri­als for an ac­cel­er­at­ed nod in that in­di­ca­tion back in 2018 failed to show ben­e­fit in ex­tend­ing pa­tients’ lives, the drug­mak­er said Tues­day.

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