Libtayo
Libtayo ingredients
| Active ingredient | Strength |
|---|---|
| Cemiplimab | 50 mg/mL |
What Libtayo is used for
The FDA lists the approved uses on the official label (below). In the EU, cemiplimab is approved as Libtayo for:
Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation. Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria). Basal Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). Non-Small Cell Lung Cancer Libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in … (the exact criteria are in the o…
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Libtayo
- Generic name
- Cemiplimab-rwlc
- Made by
- Regeneron Pharmaceuticals, Inc.
- Forms
- Injection
- Given
- Intravenous
- FDA approval
- Biologic licence (BLA) BLA761097
- On the US market since
- 2018
Official information
- Libtayo prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Cemiplimab-rwlc)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Libtayo?
Libtayo (Cemiplimab-rwlc) is a cancer medicine made by Regeneron Pharmaceuticals, Inc., approved by the US FDA.
What are the ingredients of Libtayo?
Libtayo contains Cemiplimab (50 mg/mL).
Is Libtayo approved in Europe?
The same active substance is approved in the EU as Libtayo.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA