It has been announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of cemiplimab.
The CHMP recommended its conditional approval for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.
Cemiplimab is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1).
If approved, cemiplimab would be the first and only treatment approved for certain patients with advanced CSCC in the European Union (EU).
CSCC is one of the most commonly diagnosed skin cancers worldwide.
In Europe, CSCC occurs twice as often as melanoma and its incidence is estimated to be increasing substantially in some countries.
Although the majority of patients with CSCC have a good prognosis when the cancer is found early, the cancer can be especially difficult to treat when it progresses to advanced stages.
Advanced CSCC includes both patients with locally advanced disease (where the cancer invades deeper layers of the skin or spreads nearby) and patients with metastatic disease (when the cancer spreads to other parts of the body).
The CHMP opinion is based on data from the pivotal, open-label, multi-centre, non-randomised Phase II EMPOWER-CSCC-1 trial (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-centre, open-label, non-randomised Phase I trial.
Together, the trials represent the largest prospective dataset of advanced CSCC patients.
As part of the conditional approval, additional data from the trial - including results from a newly added group to the trial to further confirm the benefit-risk profile of cemiplimab.
The European Commission is expected to make a final decision on the application for cemiplimab in the coming months.