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Treats metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC…. Sold as Libtayo. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Cemiplimab-Rwlc (sold as Libtayo), first approved Sep 28, 2018, with 10 new uses approved and 0 published complete response letters.
First approved: Sep 28, 2018
Applications: 1
New uses approved: 10
Complete response letters: 0
Medicare spending, 2025: $434M
First approved in the EU: Jun 28, 2019
First approved in Japan: Dec 23, 2022
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in the EU 9 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
Libtayo, new substanceRegeneron Ireland Designated Activity Company (DAC) · Jun 28, 2019
Approvals in Japan (PMDA)
First approved in Japan 51 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
LibtayoA drug with a new indication for the treatment of unresectable advanced or recurrent non-small-cell lung cancer. · Regeneron Japan KK · Sep 19, 2025
Libtayo, new ingredientA drug with a new active ingredient indicated for the treatment of advanced or recurrent cervical cancer that has progressed after cancer chemotherapy. · Sanofi K.K. · Dec 23, 2022 · Review report
Clinical Trials
26 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Regeneron Pharmaceuticals