Amgen applies for EU approval of new melanoma drug

Amgen has applied for European Medicines Agency approval of an investigational oncolytic immunotherapy for the treatment of regionally or distantly metastatic melanoma.

A marketing authorisation application has been filed with the EU regulator, marking the first time that an oncolytic immunotherapy has been submitted for European approval. The drug is administered as an intralesional injection that is designed to initiate a systemic anti-tumour immune response.

The application is supported by clinical data from more than 400 patients and is based on a global, randomised, open-label phase III trial showing the strong safety and efficacy performance of the drug.

It has been shown to improve survival rates among patients with unresected stage IIIB, IIIC or IV melanoma, compared to granulocyte-macrophage colony-stimulating factor therapy.

This latest filing follows on from the recent submission of a biologics licence application for the therapy to the US Food and Drug Administration.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "The submission of the marketing authorisation application in Europe for talimogene laherparepvec brings us a step closer to helping address an unmet medical need for patients with metastatic melanoma."