FDA Approval Date for Opdivo and/or Keytruda - Nonsquamous NSCLC - 1270596

Fri, 07/24/2015 - 14:34

Hi, does anyone know the approximate date or timeline for the FDA to approve Opdivo and/or Keytruda for Non-Squamous NSCLC? I know Keytruda is currently under FDA priority review for both non-squamous and squamous NSCLC, but not sure if Opdivo is as well. If anyone has further insight or better timeline estimates, I'd really appreciate it. Thank you.

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For Nivolumab, deadline is January 2, 2016.

"Nivolumab (Opdivo) has received an FDA priority review designation for patients with previously treated nonsquamous non­–small cell lung cancer (NSCLC), according to the developer of the PD-1 inhibitor, Bristol-Myers Squibb (BMS). Under the expedited process, the FDA’s decision deadline is January 2, 2016."


Effective October 2, 2015 KEYTRUDA® (pembrolizumab) is FDA approved.

"KEYTRUDA is the first and only anti-PD-1 therapy approved for both squamous and non-squamous metastatic NSCLC."


That is indeed very good news for the many people who will benefit from nivo. We are all very excited here on Grace!

Hope you are well,