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
Further information
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