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Libtayo FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 22, 2021.

FDA Approved: Yes (First approved September 28, 2018)
Brand name: Libtayo
Generic name: cemiplimab-rwlc
Dosage form: Injection
Company: Sanofi
Treatment for: Squamous Cell Carcinoma, Basal Cell Carcinoma, Non-Small Cell Lung Cancer

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and non-small cell lung cancer (NSCLC).

Cutaneous Squamous Cell Carcinoma (CSCC)

  • Libtayo is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.

Basal Cell Carcinoma (BCC)

  • Libtayo is indicated for the treatment of patients with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
  • Libtayo is indicated for the treatment of patients with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.1
  • 1The mBCC indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for mBCC may be contingent upon verification and description of clinical benefit.

Non-Small Cell Lung Cancer (NSCLC)

  • Libtayo is indicated for the first-line treatment of patients with NSCLC whose tumors have high PD-L1 expression (TPS ≥ 50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is locally advanced (patients are not candidates for surgical resection or definitive chemoradiation) or metastatic.

Development Timeline for Libtayo

DateArticle
Feb 22, 2021Approval  FDA Approves Libtayo (cemiplimab-rwlc) Monotherapy for Patients with First-line Advanced Non-Small Cell Lung Cancer with PD-L1 Expression of ≥50%
Feb  9, 2021Approval  FDA Approves Libtayo (cemiplimab-rwlc) as First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma
Sep 28, 2018Approval  FDA Approves Libtayo (cemiplimab-rwlc) for Advanced Cutaneous Squamous Cell Carcinoma
Jun  4, 2018New England Journal of Medicine Publishes Pivotal Cemiplimab Trials Showing Positive Results in Advanced Cutaneous Squamous Cell Carcinoma
Apr 30, 2018FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
Dec 13, 2017Sanofi and Regeneron Announce Positive Topline Pivotal Results for PD-1 Antibody Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma
Sep  8, 2017Sanofi and Regeneron Announce That Cemiplimab (REGN2810) has Received FDA Breakthrough Therapy Designation for Advanced Cutaneous Squamous Cell Carcinoma

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.