Sanofi-Regeneron's Libtayo combo accepted for review by FDA for lung cancer subtype
magicmine/iStock via Getty Images


The U.S. Food and Drug Administration (FDA) accepted to review Regeneron Pharmaceuticals (REGN
+1.9%) and Sanofi's (SNY
-0.2%) application seeking approval of Libtayo (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC).

The FDA is expected to make a decision by Sept. 19.
The supplemental Biologics License Application is backed by positive data from a phase 3 trial.