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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