Amgen is now months away from a European approval with Imlygic (also known as T-VEC) – the first oncolytic immunotherapy for advanced melanoma. The Committee for Medicinal Products for Human Use (CHMP) and the scientific committee of the European Medicines Agency (EMA), have reacted positively.
Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing the pigment to skin. It is the most aggressive and serious form of skin cancer, and remains a significant public health concern in the EU. In 2012, it was estimated that there were 56,000 new cases of melanoma in France, Italy, Spain, Germany and the UK, causing almost 9,500 deaths.
Amgen’s oncolytic immunotherapy is using a genetically modified strain of the herpes virus to invade tumors and replicate itself (e.g. OncoVex). Also known as talimogene laherparepvec (T-VEC) the viral-vectored kills cancer cells along the way and stimulates an immune response (by releasing GM-CSF tumoric antigens).