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Libtayo FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 15, 2022.

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. The 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 in combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
  • Libtayo is indicated as a single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

Development timeline for Libtayo

DateArticle
Nov  8, 2022Approval Libtayo (cemiplimab-rwlc) in Combination with Chemotherapy Approved by the FDA as First-line Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC)
Oct 14, 2022Libtayo Receives Positive CHMP Opinion Recommending Approval to Treat Advanced Cervical Cancer
Aug  3, 2022Costimulatory Bispecific Antibody Shows Encouraging Anti-tumor Activity When Combined with PD-1 Inhibitor Libtayo in Advanced Metastatic Castration-resistant Prostate Cancer
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

See also

Libtayo (cemiplimab-rwlc) Consumer information

Further information

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