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EMA Recommends Extension of Indications for Cemiplimab

New indication concerns a combination with platinum‐based chemotherapy for the first‐line treatment of NSCLC expressing PD-L1 in ≥ 1% of tumour cells, with no EGFR, ALK or ROS1 aberrations
03 Mar 2023
Immunotherapy;  Cytotoxic Therapy
Non-Small Cell Lung Cancer

On 23 February 2023, 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 holder for this medicinal product is Regeneron Ireland Designated Activity Company (DAC).

The CHMP adopted a new indication as follows:

Non-Small Cell Lung Cancer (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.

For information, the full indications for Libtayo will be as follows (new indication 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

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.

LIBTAYO in combination with platinumbased 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, 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.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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