Recommendation based on a Phase 3 Libtayo trial that was first and only to demonstrate significantly improved survival compared to chemotherapy in the second-line setting irrespective of PD-L1 expression status or tumor histology
TARRYTOWN, N.Y., Oct. 14, 2022 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) as a monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. The European Commission is expected to make a final decision on the application in the coming months.
The positive opinion is supported by results from the Phase 3 EMPOWER-Cervical 1 trial. In the trial (n=608), the…
