Sanofi/Regeneron's Libtayo Wins FDA Approval For A Type Of Skin Cancer

  • Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) immunotherapy Libtayo (cemiplimab-rwlc) has scored approval from the FDA for the treatment of advanced basal cell carcinoma (BCC), the most common type of skin cancer in the U.S.
  • The FDA has indicated Libtayo for treating previously-treated, advanced BCC patients who have already received a hedgehog pathway inhibitor (HHI) or who cannot be treated with an HHI.
  • The PD-1 inhibitor has been granted full approval for patients with locally advanced BCC and accelerated approval for patients with metastatic BCC, which has spread to other parts of the body.
  • In 2018, Libtayo was approved as the first systemic treatment for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
  • Price Action: REGN closed 0.8% down at $490.68, while, SNY closed 0.5% higher at $48.86.

Posted In: Skin CancerBiotechNewsFDAGeneral

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