FDA promis­es speedy re­view on mov­ing Mer­ck­'s Keytru­da up as first-line head and neck can­cer ther­a­py

Armed with cru­cial over­all sur­vival da­ta in head and neck can­cer, Mer­ck is now steer­ing Keytru­da down the pri­or­i­ty re­view speed­way the FDA has just opened up for it.

An ap­proval here — for the front­line use of Keytru­da in head and neck cell car­ci­no­ma, both as a monother­a­py and in com­bi­na­tion with chemo — would fol­low an ac­cel­er­at­ed ap­proval for re­cur­rent or metasta­t­ic cas­es grant­ed in 2016.

As Keytru­da set­tles in­to its mar­ket-lead­ing place, bol­stered by a dom­i­nant po­si­tion in front­line lung can­cer, Mer­ck has been busy push­ing ear­li­er us­es of the PD-1 in oth­er in­di­ca­tions, in­clud­ing kid­ney can­cer and esophageal car­ci­no­ma.

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