Regeneron Receives CHMP’s Positive Opinion Recommending the Approval of Libtayo (cemiplimab) for NSCLC and BCC

May 24, 2021 Auto Bot approval, CHMP, Libtayo, NSCLC, Positive Opinion, Regeneron, regulatory 0

Shots:

  • The CHMP recommended the approval of Libtayo as a 1L treatment for adults with NSCLC expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1 aberrations, based on the P-III EMPOWER-Lung 1 study
  • The positive opinion of Libtayo in LA and mBCC is based on P-II EMPOWER-BCC 1 study in patients who either progressed on HHI therapy, had not had an objective response after 9mos. on HHI therapy, or were intolerant of prior HHI therapy
  • The EC is expected to decide on both indications in the coming months

Click here to­ read full press release/ article | Ref: Regeneron | Image: Investros Business Daily

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