Wednesday, April 13, 2016

Merck's Keytruda® Keeps Heat On BMS's Opdivo® With Head And Neck Cancer FDA Submission

I'll have more soon -- on Off the road now -- at a board meeting today, but BMS's nivolumab, branded as Opdivo®, still holds the lead in this fairly high burden indication. This morning's announcement means that the FDA has blessed pembrolizumab, or Keytruda® with priority review status -- and with an aspirational approval date of August 9, 2016. We shall see.

From an earlier note, at OncLive then:

. . . .Both nivolumab and pembrolizumab have demonstrated activity in patients with head and neck cancer. The phase III CheckMate-141 trial, which examined the anti–PD-1 agent nivolumab versus investigator’s choice of cetuximab (Erbitux), methotrexate, or docetaxel in patients with platinum-refractory squamous cell carcinoma of the head and neck, was stopped early after it was determined nivolumab had met its primary endpoint of overall survival. . .

This particular race will be neck-and-neck (rim-shot!) -- but overall, BMS still holds a significant lead.  Travel safely one and all!

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