Cemiplimab
Pd-1/Pd-L1 (Programmed Cell Death Protein 1/Death Ligand 1) Inhibitors
Sold as Libtayo
- Drug class
- Pd-1/Pd-L1 (Programmed Cell Death Protein 1/Death Ligand 1) Inhibitors
- Availability
- See label
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 5
Overview
Cemiplimab is an active pharmaceutical ingredient in the Pd-1/Pd-L1 (Programmed Cell Death Protein 1/Death Ligand 1) Inhibitors group (L01FF). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 3 | May 15, 2026 |
| EU European Union | EMA | 1 | January 20, 2026 |
| CA Canada | Health Canada | 1 | June 1, 2026 |
GBUnited Kingdom· MHRA
3 products
Uses
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.
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 ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: • locally advanced NSCLC who are not candidates for definitive chemoradiation, or • metastatic NSCLC.
LIBTAYO in combination with platinum-based chemotherapy is indicated for the firstline treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: • locally advanced NSCLC who are not candidates for definitive chemoradiation, or • metastatic NSCLC.
EUEuropean Union· EMA
1 product
Uses
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.
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 ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: • locally advanced NSCLC who are not candidates for definitive chemoradiation, or • metastatic NSCLC.
3 LIBTAYO in combination with platinum-based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: • locally advanced NSCLC who are not candidates for definitive chemoradiation, or • metastatic NSCLC.
CACanada· Health Canada
1 product
1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Brands in Canada (1)
Drug interactions
Known interactions involving Cemiplimab. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB452320001 · revised May 15, 2026
- [2]European Medicines Agency · EMEA/H/C/004844 · revised January 20, 2026
- [3]Health Canada (DPD) · 02487144 · revised June 1, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.