2023-03-29 07:31:48 ET
- 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 ?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.
For further details see:
Regeneron Libtayo gets expanded approval in EU for lung cancer subtype