Regeneron Says CHMP Recommends Libtayo For EU Approval As Adjuvant Treatment Of CSCC

Regeneron Pharmaceuticals

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(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

The European Commission is expected to make a final decision on the application in the coming months. Libtayo was approved by the U.S. Food and Drug Administration (FDA) for these patients in the U.S. earlier this month.

The positive opinion is supported by results from the global Phase 3 C-POST trial investigating adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence following surgery and radiation.

In the trial, Libtayo reduced the risk of disease recurrence or death by 68% compared to placebo. Fewer patients treated with Libtayo had locoregional or distant recurrence compared with those who received placebo.

In the trial, adverse events (AEs) occurred in 91% of patients receiving Libtayo and 89% of patients receiving placebo.

C-POST was a randomized, placebo-controlled, double-blind, multicenter, global Phase 3 trial investigating Libtayo versus placebo as adjuvant treatment for patients.