Sanofi/Regeneron skin cancer drug among flurry of decisions from EU regulators

A new drug for advanced skin cancer and a long-lasting treatment for haemophilia A are among a group of new drugs that look set for the European market following backing from regulators.

The European Medicines Agency’s CHMP scientific committee recommended that Sanofi and Regeneron’s Libtayo (cemiplimab) should get a licence in adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), if they cannot get curative surgery or radiotherapy.

Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor and in the likely event of approval by the European Commission it will be the only treatment approved for certain patients with CSCC in the EU.

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 conditional decision was based on the mid-stage EMPOWER-CSCC-1 trial and EU regulators will require confirmatory data from a late stage trial to grant a full licence.

Until then the companies will have to renew the drug’s licence every year.

Libtayo is approved in the US for the treatment of patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation, and in other countries for similar indications.

In a separate decision, the CHMP gave a positive opinion for Novo Nordisk’s Esperoct (turoctocog alfo pegol, N8-G), recommending authorisation for adolescents and adults with haemophilia A.

Esperoct is a long-lasting version of NovoEight, requiring a dose roughly every four days, as opposed to every two days when administered as a prophylactic treatment to prevent bleeding.

Positive opinions from the CHMP are passed on to the European Commission, which nearly always grants a marketing authorisation within a few months.