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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chucksan

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."

http://www.onclive.com/web-exclusives/fda-grants-nivolumab-priority-rev…

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."

catdander

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,
Janine