CHMP recommends conditional marketing authorisation for cemiplimab for squamous cell carcinoma

The CHMP has recommended the granting of a conditional marketing authorisation for cemiplimab (Libtayo) for the treatment of advanced cutaneous squamous cell carcinoma. Conditional marketing authorisations are granted to medicines that fulfil unmet medical needs when the benefits of immediate availability outweigh the risks associated with the need for additional trial data.

Cemiplimab is an immune checkpoint inhibitor that binds to the programmed cell death-1 (PD-1) receptor on T cells, blocking its interaction with receptor ligands PD-L1 and PD-L2 and thus removing inhibition of the immune response. It is a monoclonal antibody therapy that is administered by intravenous infusion every three weeks. If marketing authorisation is granted by the EC, it will be indicated as monotherapy for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

In clinical trials including a total of 108 adults with locally advanced or metastatic cutaneous squamous cell carcinoma, the objective response rate to cemiplimab therapy was 47%. The most common side-effects were fatigue, rash and diarrhoea. As with other immune checkpoint inhibitors, severe immune-mediated adverse reactions can occur in any organ system or tissue, and patients receiving therapy should be monitored for the symptoms and signs of these.

NICE is currently appraising cemiplimab for the treatment of cutaneous squamous cell carcinoma, with final guidance expected in July 2019. The drug is also being evaluated in clinical trials for the treatment of non-small cell lung cancer and cervical cancer.

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