Regeneron's Libtayo approved in EU for expanded use in cervical cancer
artJazz


The European Commission (EC) approved the expanded use of Regeneron Pharmaceuticals' (NASDAQ:REGN) Libtayo (cemiplimab) as monotherapy to treat adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
In October, a panel of the European Medicines Agency (EMA) had recommended the expanded approval of Libtayo for this ues.

Regeneron said Libtayo was approved by the EC as the first immunotherapy in second line recurrent or metastatic cervical cancer irrespective of PD-L1 expression level or tumor histology.
Libtayo is now approved to treat four cancer types in the EU, according to the company.
The drug was already approved to treat certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, and advanced non-small cell lung cancer.
The EC greenlight was backed by data from a phase 3 trial called EMPOWER-Cervical 1.
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.