Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Home
          Drugs
          Development & Approval Process | Drugs
          Drug Approvals and Databases
          Resources for Information | Approved Drugs
          FDA D.I.S.C.O. Burst Edition: FDA approval of Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for non-small cell lung cancerResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for non-small cell lung cancer
  
  	
    Share
    Post
    Linkedin

    Email
    PrintPodcast

Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on a recent FDA cancer drug approval.

On November 8, 2022, the FDA approved cemiplimab-rwlc (brand name Libtayo,) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer with no epidermal growth factor gene, anaplastic lymphoma kinase, or ROS-1 aberrations.

Efficacy was evaluated in Study 16113, a randomized, multicenter, multinational, double-blind, active-controlled trial in 466 patients with advanced non-small cell lung cancer who had not received prior systemic treatment. Patients were randomized (2:1) to either cemiplimab-rwlc plus platinum-based chemotherapy every 3 weeks for 4 cycles followed by cemiplimab-rwlc and maintenance chemotherapy or placebo plus platinum-based chemotherapy every 3 weeks for 4 cycles followed by placebo and maintenance chemotherapy.

The main efficacy outcome measure was overall survival. Additional efficacy outcome measures were progression-free survival and overall response rate as assessed by blinded independent central review.

Cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus chemotherapy. Median overall survival was 21.9 months in the cemiplimab-rwlc plus chemotherapy arm and 13.0 months in the placebo plus chemotherapy arm. Median progression-free survival per blinded independent central review was 8.2 months in the cemiplimab-rwlc plus chemotherapy arm and 5.0 months in the placebo plus chemotherapy arm. Confirmed overall response rate per blinded independent central review was 43% and 23% in the respective treatments.

The most common adverse reactions occurring in more than 15% of patients were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatFDA.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.

Follow the Division of Drug Information on Twitter @FDA_Drug_Info and the Oncology Center of Excellence @FDAOncology. Send your feedback via email to FDAOncology@fda.hhs.gov. Thanks for tuning in to the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      12/05/2022Resources for Information | Approved Drugs

          
                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop