Merck Serono receives EU approval for Erbitux label update

Merck Serono has received European Commission approval for a new label update for its colorectal cancer drug Erbitux, allowing it to be used among a wider range of patients.

The type II variation to amend the product information will update the indication for Erbitux to include the treatment of patients with RAS wild-type metastatic colorectal cancer.

This decision is based on the totality of data emerging on the role of RAS tumour status in the benefit-risk profile of the drug, with new biomarker data from the recent Opus trial proving instrumental in securing this approval.

Results from these studies suggest that patients with RAS wild-type tumours may benefit from treatment with Erbitux, while patients with RAS mutant tumours may not.

Belen Garijo, president and chief executive officer of Merck Serono, said: "We will now be working with the regulatory agencies to effectively communicate the implications of this label change to healthcare professionals and patients."

Erbitux has been approved for the treatment of colorectal cancer in 93 countries and for the treatment of squamous cell carcinoma of the head and neck in 91 territories.