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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER