- Regeneron Pharmaceuticals ( NASDAQ: REGN ) on Friday said that a panel of the European Medicines Agency (EMA) recommended the expanded approval of Libtayo (cemiplimab) as a monotherapy to treat adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
- In June, Sanofi ( NASDAQ: SNY ) said it was selling worldwide exclusive license rights to Libtayo to Regeneron for $900M upfront, plus royalties and other potential payments.
- The positive opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) was supported by data from a phase 3 trial called EMPOWER-Cervical 1.
- The European Commission, which generally follows the opinion of the CHMP, will now decide on the drug's expanded approval.
- Libtayo is currently approved in the EU and certain other countries to treat certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, and advanced non-small cell lung cancer.
For further details see:
EMA committee recommends expanded approval of Regeneron's Libtayo for cervical cancer