FDA Approves Regeneron/Sanofi's Libtayo For Front-Line Lung Cancer

The FDA approved expanded use of Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi’s SA (NASDAQ: SNY) immunotherapy Libtayo (cemiplimab-rwlc) as monotherapy in newly diagnosed advanced lung cancer, marking the third approval for Libtayo and second this month.
The drug is now cleared for adults with non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression of at least 50%, a protein that’s correlated with response to immunotherapy, and have metastatic or locally advanced tumors that can’t be removed by surgery and must not have EGFR, ALK or ROS1 aberrations.
Just two weeks ago, Libtayo was approved for advanced basal cell carcinoma, the most common skin cancer type in the U.S.
Simultaneously, the agency also approved Agilent Technologies’ (NYSE: A) PD-L1 IHC 22C3 pharmDx as a companion diagnostic to identify NSCLC patients eligible for cemiplimab treatment on a PD-L1 expression of at least 50%.
Libtayo was approved in 2018 for metastatic cutaneous squamous cell carcinoma, a common form of skin cancer.
Price Action: SNY, REGN and A closed 0.6%, 2.08% and 2.7% lower at $46.36, $460.58 and $123.50, respectively on Monday.