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T-VEC becomes first viral immunotherapy approved in Europe

A viral immunotherapy for cancer has become the first of its kind to be approved by the European Medicines Agency for use in adults with advanced melanoma.

The treatment, Talimogene laherparepvec, or T-VEC for short, is a completely new type of cancer treatment called oncolytic immunotherapy – which targets cancer cells with viruses and directs the immune system against them.

Researchers from The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust led the UK arm of the major phase III trial for T-VEC, published in the Journal of Clinical Oncology in May, which was the first to definitively show patient benefit for a viral immunotherapy for cancer.

T-VEC is a modified form of the herpes simplex virus which multiplies inside cancer cells and bursts them from within. It has been genetically engineered to produce a molecule called GM-CSF, which stimulates the immune system to attack and destroy the tumour.

Currently, only adults with melanoma that cannot be removed by surgery and that has spread locally or around the body will qualify to receive the treatment. However, T-VEC is currently in clinical trials for earlier stages of melanoma and different types of cancer. It is also being tested in combination with other cancer immunotherapies and radiotherapy.

The decision by the EMA follows approval by the Food and Drug Administration in the US at the end of October.

Professor Kevin Harrington, Professor of Biological Cancer Therapies at The Institute of Cancer Research, London, who led the UK-arm of the T-VEC phase III trial, said: “T-VEC kills cancer cells in two ways – by attacking them directly and by directing the patient’s own immune system against the tumour. It has today become the first viral immunotherapy to gain a licence in Europe, and is not only effective but also has relatively mild side-effects compared with other types of immunotherapy on the market.

“I’m really excited by the endorsement by the European Medicines Agency. It is an important first step that paves the way for T-VEC being made available for patients with metastatic melanoma – a cancer that has largely been regarded as untreatable for the majority of patients. NICE has already started evaluating the treatment, and I hope there are no delays in making it available to patients on the NHS.”


immunotherapy oncolytic viruses T-VEC
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