Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an ear­ly shot in the bat­tle against drug­mak­ers that whiff on con­fir­ma­to­ry stud­ies to sup­port ac­cel­er­at­ed ap­provals, the FDA or­dered Bris­tol My­ers Squibb late last year to give up Op­di­vo’s ap­proval in SCLC. Now, Mer­ck is next on the fir­ing line — are we see­ing the FDA buck­ling down on post-mar­ket­ing of­fend­ers?

Mer­ck has with­drawn its mar­ket­ing ap­proval for PD-1 in­hibitor Keytru­da in metasta­t­ic small cell lung can­cer as part of what it de­scribes as an “in­dus­try-wide eval­u­a­tion” by the FDA of drugs that do not meet the post-mar­ket­ing check­points on which their ac­cel­er­at­ed nods were based, the com­pa­ny said Mon­day.

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