Regeneron and Sanofi pull Libtayo app in cervical cancer, citing post-market study disagreement with FDA

Regeneron and Sanofi pull Libtayo app in cervical cancer, citing post-market study disagreement with FDA

Source: 
Endpoints
snippet: 

Sanofi and Regeneron on Friday said they’ve decided to pull their sBLA for their PD-1 Libtayo (cemiplimab-rwlc) in second-line cervical cancer after the companies and the FDA were not able to align on certain post-marketing studies that presumably would’ve been required had it won approval.