# Cemiplimab

Cemiplimab (Libtayo, Regeneron Ireland Designated Activity Company (DAC)) has 6 EU-approved indications in 4 tumour types. 2 need a biomarker result: PD-L1 (2).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PD-L1 TPS ≥ 1%, EGFR/ALK/ROS1-negative | + platinum-based chemotherapy | 1st line, advanced | Locally advanced patients must not be candidates for definitive chemoradiation |
| PD-L1 TPS ≥ 50%, EGFR/ALK/ROS1-negative | Monotherapy | 1st line, advanced | Locally advanced patients must not be candidates for definitive chemoradiation |

### Cervical cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line, advanced | After platinum-based chemotherapy |

### Cutaneous squamous cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Adjuvant | After surgery and radiation; High risk of recurrence |
| None | Monotherapy | Advanced | Not candidates for curative surgery or curative radiation |

### Basal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line, advanced | Progressed on or intolerant to a hedgehog pathway inhibitor (HHI) |

## Products

### Libtayo

- Company: Regeneron Ireland Designated Activity Company (DAC)
- Target: PD-1 inhibitor (antibody)
- Class: PD-1/PD-L1 (programmed cell death protein 1/death ligand 1) inhibitors
- ATC: L01FF06
- EU approval: 28 Jun 2019
- Label revised: 10 Dec 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/libtayo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/libtayo

Mechanism (SmPC section 5.1): Binds to the PD-1 receptor and blocks interaction with PD-L1 and PD-L2, potentiating T-cell anti-tumour responses.

## Label wording

- **Cemiplimab** (Libtayo), Cutaneous squamous cell carcinoma, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf)
- **Cemiplimab** (Libtayo), Cutaneous squamous cell carcinoma, adjuvant: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf)
- **Cemiplimab** (Libtayo), Basal cell carcinoma, 2nd line, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf)
- **Cemiplimab** (Libtayo), Non-small cell lung cancer, 1st line, advanced: “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” [SmPC](https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf)
- **Cemiplimab** (Libtayo), Non-small cell lung cancer, 1st line, advanced: “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” [SmPC](https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf)
- **Cemiplimab** (Libtayo), Cervical cancer, 2nd line, advanced: “LIBTAYO as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/cemiplimab