The combination of Libtayo and platinum-based chemotherapy has been approved to treat advanced non-small cell lung cancer. Credit: Ed Uthman/ Flickr (Creative Commons).

The European Commission (EC) has granted approval for Regeneron Pharmaceuticals’ Libtayo (cemiplimab), along with platinum-based chemotherapy, as the first-line treatment for PD-L1 expression positive advanced non-small cell lung cancer (NSCLC) in adult patients.

The combination therapy has also been indicated for patients who do not have EGFR, ALK or ROS1 aberrations and whose tumours are metastatic or locally advanced, and for those who are not candidates for definitive chemoradiation.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Developed using Regeneron’s VelocImmune technology, Libtayo is a complete human monoclonal antibody that targets the immune checkpoint receptor PD-1 on T cells.

It has been approved to treat patients with advanced NSCLC, advanced cutaneous squamous cell carcinoma (CSCC), advanced basal cell carcinoma (BCC), and advanced cervical cancer in the EU and other countries.

The EC granted the approval based on data obtained from the international, randomised, multicenter Phase III EMPOWER-Lung 3 trial of the Libtayo combination against platinum-doublet chemotherapy alone in 466 patients.

In November 2022, the US Food and Drug Administration (FDA) granted approval for the combination of Libtayo and platinum-doublet chemotherapy to treat advanced NSCLC, regardless of PD-L1 expression.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Regeneron Pharmaceuticals Translational and Clinical Sciences, Oncology senior vice-president Israel Lowy said: “Today’s approval considerably expands the number of people in Europe with advanced non-small cell lung cancer who are eligible for Libtayo-based first-line treatment, including those with PD-L1 expression ranges most commonly seen in real-world practice.

“We are proud that Libtayo continues to distinguish itself among PD-1 pathway blockers, as just one of two PD-1 inhibitors to be approved for use across squamous and non-squamous forms of advanced NSCLC in both combination and monotherapy settings. This marks the fifth approval for Libtayo in Europe.”