The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval for Amgen’s Imlygic drug to treat melanoma.
Imlygic, also known as talimogene laherparepvec (T-Vec), is recommended to treat adults with unresectable melanoma that is regionally or distantly metastatic with no bone, brain, lung or other visceral disease.
The drug, administered through intralesional injection, is designed to cause the death of tumor cells and to start an anti-tumor immune response.
In the phase 3 study, which was the basis for the CHMP opinion, Imlygic significantly extended the primary endpoint of durable response rates (DRR) compared with granulocyte-macrophage colony-stimulating factor (GM-CSF).
The study randomized 436 patients with unresected stage IIIB, IIIC or IV melanoma.
Amgen executive vice president of research and development Sean Harper said: “Metastatic melanoma continues to be one of the most difficult-to-treat cancers, often requiring the use of multiple treatment modalities.
“Despite recent advances, the five-year survival rate for patients who cannot be cured with surgery remains unacceptably low, demonstrating the critical need for additional approaches to control this disease.”
The European Commission is expected to take a decision on the marketing authorization for Imlygic in the coming months. The drug is also under review by the US Food and Drug Administration.
Melanoma is a serious form of skin cancer which remains a significant public health concern in the European Union (EU).
It was estimated in 2012 that there were 56,000 new melanoma cases in France, Italy, Spain, Germany and the UK, resulting in about 9,500 deaths.
Published 26 October 2015