Page URL:

US approves modified-virus cancer treatment

2 November 2015
Appeared in BioNews 826

The US Food and Drug Administration has approved a drug derived from a genetically modified herpes virus for the treatment of melanoma that cannot be removed by surgery.

Imylgic (chemical name talimogene laherparepvec), manufactured by Amgen, is the first oncolytic viral therapy to receive regulatory approval.

The drug works by invading and replicating within cancer cells, eventually causing them to burst – a natural ability of the herpes virus.

But the modified virus also carries with it a gene fragment encoding a protein called granulocyte-macrophage colony stimulating factor (GM-CSF). When produced by the virus, this stimulates the patient's immune system to recognise and destroy cancer cells.

The modified virus is also able to travel in the patient's bloodstream and infect other tumour cells. It can also enter healthy cells but is unable to replicate within them, thus sparing them.

Imlygic's approval follows the outcome of a multicentre, randomised, phase 3 clinical trial involving 436 patients. Patients in the study were treated over a six-month period with either Imlygic or GM-CSF injected directly into the melanoma lesions.

The study showed a reduction in lymph node lesion size in 16.3 percent of the patients treated with Imlygic compared to 2.1 percent in the GM-CSF arm. The effect of the drug and overall survival was largest in patients with unresectable melanoma that had not spread beyond the skin and lymph nodes.

But the study showed the drug had no benefit for patients with melanoma that had spread to the brain, lungs and other internal organs.

The European Medicines Agency has also recommended the drug for approval, setting the stage for marketing authorisation in Europe.

Melanoma is an aggressive form of skin cancer and a leading cause of death from skin disease. Ultraviolet light and unprotected sun exposure are the main risk factors. When detected early, melanoma can be removed surgically but the prognosis is poor for the more advanced stage of the disease, particularly when cancer cells have metastasized to other parts of the body.

'As an oncolytic viral therapy, Imlygic has a unique approach, and provides another option for treating eligible patients with unresectable disease that has recurred after initial surgery' said Professor Howard Kaufman, from the Rutgers Cancer Institute of New Jersey, principal investigator in the Imlygic trial.

There are at least six biotechs and research groups working on oncolytic viruses and about a dozen clinical trials currently ongoing, meaning Imlygic may be the first of many to emerge.

'The era of the oncolytic virus is probably here,' Dr Stephen Russell, a specialist from the Mayo Clinic in Rochester, Minnesota told Nature News. 'I expect to see a great deal happening over the next few years.'

Amgen's Imlygic May Not Boost Earnings But It Will Change Cancer Care
Forbes |  28 October 2015
Cancer-fighting viruses win approval
Nature News |  29 October 2015
FDA approves Amgen's injected immunotherapy for melanoma
Reuters |  27 October 2015
FDA approves first-of-its-kind product for the treatment of melanoma
FDA |  27 October 2015
First oncolytic immunotherapy medicine recommended for approval
European Medicines Agency |  23 October 2015
US approval for drug that turns herpes virus against cancer
The Guardian |  28 October 2015
29 May 2018 - by Martha Henriques 
A virus has been reprogrammed to attack ovarian cancer cells in mice, effectively destroying tumours...
30 November 2015 - by Dr Jane Currie 
Scientists have used genome-editing technology to identify a core set of 1580 genes that are essential to human life...
16 November 2015 - by Meetal Solanki 
Researchers in the USA have mapped the sequence of genetic changes from early skin lesions, such as common moles, to malignant skin cancer...
13 April 2015 - by Dr Nicoletta Charolidi 
A new type of cancer vaccine that enriches the immune system with tailor-made anti-tumour antibodies has shown early signs of promise...
22 September 2014 - by Dr Lanay Griessner 
A skin cancer drug designed to be effective in patients whose cancer is driven by a specific gene mutation has been recommended by the National Institute for Health and Care Excellence to treat patients with advanced melanoma...
5 November 2012 - by Maria Sheppard 
A drug which prolongs life in a form of skin cancer associated with a genetic mutation has been recommended for use on the NHS...
11 June 2012 - by Dr Tamara Hirsch 
Two drugs targeting advanced melanoma linked to a mutation in the BRAF gene are more effective than current chemotherapy at slowing the progress of the skin cancer, clinical trial results indicate...
28 May 2012 - by James Brooks 
A drug that mimics broken strands of DNA and pushes treatment-resistant cancer cells to autodestruct has produced encouraging results in a first clinical trial. The medicine, DT01, is the forerunner for a new class of drug developed by researchers at the Institut Curie in Paris...
to add a Comment.

By posting a comment you agree to abide by the BioNews terms and conditions

Syndicate this story - click here to enquire about using this story.