Libtayo - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

cemiplimab

Opinion

On 16 October 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Libtayo. The marketing authorisation holder for this medicinal product is Regeneron Ireland Designated Activity Company.

The CHMP adopted a new indication as follows:

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).

For information, the full indications for Libtayo will now be:

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 ≥ 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 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.

Cervical Cancer

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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold.

CHMP post-authorisation summary of positive opinion for Libtayo (EMAVR0000264999)

Reference Number: EMADOC-1700519818-2492915

Key facts

• Name of medicine:
  Libtayo
• EMA product number:
  EMEA/H/C/004844
• Active substance:
  cemiplimab
• International non-proprietary name (INN) or common name:
  cemiplimab
• Therapeutic area (MeSH):
  Carcinoma, Squamous Cell
• Anatomical therapeutical chemical (ATC) code:
  L01XC33
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  Regeneron Ireland Designated Activity Company (DAC)
• Date of opinion:
  16/10/2025
• Status:
  Positive