FDA approves cemiplimab-rwlc for locally advanced and metastatic basal
On February 9, 2021, the Food and Drug Administration granted regular approval to cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for patients with locally advanced basal cell carcinoma ...
Libtayo (cemiplimab-rwlc) FDA Approval History - Drugs.com
Oct 9, 2025 · 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 …
Libtayo® (cemiplimab) Approved in the European Union as First and …
Nov 19, 2025 · Libtayo is also currently approved in the EU for the treatment of certain patients with advanced CSCC, advanced basal cell carcinoma (BCC), advanced non-small cell lung cancer …
Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First
Oct 8, 2025 · Libtayo has been approved by regulatory authorities in more than 30 countries in one or more indications, including for certain adult patients with advanced basal cell carcinoma (BCC), …
FDA Grants Regular Approval to Cemiplimab for Metastatic Basal Cell ...
May 1, 2023 · The FDA has granted full approval to cemiplimab-rwlc (Libtayo) for the treatment of patients with metastatic basal cell carcinoma who previously received a hedgehog inhibitor (HHI) or …
Cemiplimab (Libtayo): A Patient Guide for 2025 to Treatment, Side ...
Aug 22, 2025 · Cemiplimab is a newer cancer treatment that has brought hope to patients with advanced skin and lung cancers. It is part of an exciting group of drugs called immune checkpoint …
LIBTAYO® (cemiplimab-rwlc) in Advanced NSCLC, BCC, CSCC & High …
LIBTAYO is a prescription medicine used to treat adults with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it …
Libtayo® (Cemiplimab-rwlc) Injection for Intravenous Use
Aug 2, 2024 · Abstract Libtayo ® (cemiplimab-rwlc) injection for intravenous use was recently approved by the US Food and Drug Administration (FDA) for locally advanced basal cell carcinoma (laBCC) …
Cemiplimab-rwlc Approved for Locally Advanced/Metastatic Basal Cell ...
Feb 10, 2021 · The FDA has now approved cemiplimab-rwlc (Libtayo ®, Regeneron Pharmaceuticals) for patients with locally advanced or metastatic basal cell carcinoma (BCC) who received prior …
Cemiplimab-rwlc - NCI - National Cancer Institute
FDA label information for this drug is available at DailyMed. Use in Cancer Cemiplimab-rwlc is approved to treat: Basal cell carcinoma (BCC) (a type of skin cancer). It is used in patients whose cancer …