Regeneron Libtayo gets expanded approval in EU for lung cancer subtype
keremberk


The European Commission (EC) approved the expanded use of Regeneron Pharmaceuticals' (NASDAQ:REGN) Libtayo in combination with platinum-based chemotherapy as a first-line therapy for adult patients with advanced non-small cell lung cancer (NSCLC) with â¥1% PD-L1 expression.
This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not eligible for chemoradiation.

The approval marks the second, first-line use in NSCLC and fifth indication for Libtayo (cemiplimab) in the EU, according to the company.
A panel of the European Medicines Agency (EMA) had recommended the approval of the drug for this expanded use in February.
The EC approval was backed by data from a phase 3 trial called EMPOWER-Lung 3.
Libtayo was approved for the same use in the U.S. in November 2022.
In June 2022, Sanofi (NASDAQ:SNY) announced that it was selling worldwide exclusive license rights to Libtayo to Regeneron for $900M upfront, plus royalties and other potential payments.