We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Sanofi’s and Regeneron’s Libtayo Wins FDA Approval for NSCLC

Sanofi’s and Regeneron’s Libtayo Wins FDA Approval for NSCLC

Sanofi-Regeneron_Logos.png
February 25, 2021

The FDA has approved Sanofi’s and Regeneron Pharmaceuticals’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) for the first-line treatment of nonsmall-cell lung cancer (NSCLC) with high PD-L1 expression.

The drug is now cleared in the U.S. to treat patients with advanced NSCLC whose tumors show high PD-L1 expression as determined by an FDA-approved test. Patients must have either metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.

The approval is the third for the drug and follows FDA priority review. Libtayo was also approved this month as the first immunotherapy for patients with advanced basal-cell carcinoma previously treated with a hedgehog pathway inhibitor (HHI) or for patients that are not eligible for an HHI.

View today's stories

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 21Apr

    CDER’s Most Significant Guidance Priorities for 2021: Biosimilars/Biologics, Generics/Exclusivity, Real-World Evidence, Drug Development and Digital Health

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

  • 12May

    Extractables and Leachables: 101

  • 25May

    How Can the Accelerated Availability of Pfizer-BioNTech’s COVID-19 Vaccine be Replicated?

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Novavax logo

    Novavax Admits Supply Shortages Will Delay Vaccine Production

  • Masimo’s Portable Carbon Dioxide Monitor Gets FDA Clearance

  • EMA logo European Medicines Agency logo

    EMA Reviews GSK’s and Vir’s VIR-7831 for COVID-19

  • CE mark

    Hensler Surgical Technologies Earns CE Mark for Bone-Fusion Device

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing