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Regeneron-Sanofi's Libtayo Scores CHMP's Positive Opinion For Two Advanced Cancer Settings

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  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi SA's (NASDAQ: SNY) Libtayo (cemiplimab) as monotherapy in two advanced cancers.

  • The CHMP recommended the approval of Libtayo for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK, or ROS1 aberrations.

  • Patients must have metastatic disease or locally advanced disease that is not a candidate for definitive chemoradiation.

  • The positive opinion for Libtayo in advanced NSCLC is based on results from a Phase 3 trial. Results from the pivotal trial were published in The Lancet in February 2021.

  • Libtayo was also recommended for approval in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed or are intolerant to a hedgehog pathway inhibitor (HHI).

  • Libtayo is the first immunotherapy to receive a positive CHMP opinion for this indication, the company said.

  • Libtayo is currently approved in the European Union and other countries to treat certain patients with advanced cutaneous squamous cell carcinoma (CSCC).

  • Price Action: SNY stock closed at $53.82, and REGN closed at $506.72 on Friday.

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