Amgen’s new cancer drug gets approval

Amygen's Imlygic drug, which treats adults with advanced melanoma, has been approved by the European Commission. This is the first drug in its class to gain approval within the European Union.

Imlygic (talimogene laherparepvec) will be used to treat patients whose tumour is unresectable and regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a), with no bone, brain, lung or other visceral disease.

Originally an oncolytic immunotherapy derived from the herpes (cold sore) virus, it has been modified to replicate within cancer tumours and stimulate an immune response. This then causes the death of tumour cells. It is the first drug within this class of therapy to demonstrate therapeutic benefit for patients with metastatic melanoma in a Phase III clinical trial.

Sean Harper, executive vice president of research and development at Amgen, said: "By igniting the body’s own immune system, Imlygic can initiate an anti-tumour immune response, providing meaningful and durable response rates in the early stage metastatic melanoma patient."