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EMA Recommends Extension of Indications for Cemiplimab

New indications concern the treatment of basal cell carcinoma and non-small cell lung cancer
27 May 2021
Cancer Immunology and Immunotherapy;  Lung and other thoracic tumours;  Melanoma and other skin tumours

On 20 May 2021, the European Medicines Agency’s (EMA’s) 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 cemiplimab (Libtayo).

The marketing authorisation for this medicinal product is Regeneron Ireland Designated Activity Company (DAC).

The CHMP adopted new indications as follows (new text in bold):

Cutaneous squamous cell carcinoma

Libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

Basal cell carcinoma

Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma who have progressed on or are intolerant to a hedgehog pathway inhibitor.

Non-small cell lung cancer (NSCLC)

Libtayo as monotherapy is indicated for the first-line treatment of adult patients with 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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available 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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