4:32 PM
Oct 19, 2018
 |  BC Extra  |  Company News

FDA, EMA delay review of Opdivo/Yervoy for first-line NSCLC

Bristol-Myers Squibb Co. (NYSE:BMY) said Friday that FDA and EMA have both pushed back their reviews of anti-PD-1 mAb Opdivo nivolumab plus anti-CTLA-4 mAb Yervoy ipilimumab for first-line non-small cell lung cancer. The company also released new and updated overall survival data for the combo from the Phase III CheckMate -227 trial in the indication.

BMS is seeking approval of the combo for first-line metastatic NSCLC in patients with tumor mutation burden (TMB) greater or equal to 10 mutations/megabase (mut/Mb).

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