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.

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