Amgen receives CHMP backing for approval of melanoma drug Imlygic

Amgen has announced that its new skin cancer therapy Imlygic has been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the talimogene laherparepvec therapy for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic with no bone, brain, lung or other visceral disease.

If approved by the European Commission, Amgen's drug would be the first in a class of novel agents known as oncolytic immunotherapies. It is designed to cause the death of tumour cells and to initiate an antitumour immune response.

Data from phase III trials has demonstrated that Imlygic is able to deliver improvements in durable response rates and overall survival among melanoma patients.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "We are pleased that Imlygic has received a positive opinion from the CHMP, and if approved by the European Commission, we look forward to continuing to work with European regulatory authorities to bring this innovative therapy to patients."