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Amgen gets FDA nod for virus-based melanoma therapy

Advisory committee votes in favour of drug after three month delay

The FDA has approved Amgen's Imlygic for melanoma, the first oncolytic virus therapy to get a green light in the US.

Imlygic (talimogene laherparepvec or T-Vec) is a genetically modified live Herpes simplex virus that is designed to infect and destroy melanoma lesions in the skin and lymph nodes that cannot be fully removed with surgery. The virus is administered directly into the lesions via a series of injections.

An FDA advisory committee voted 22-1 in favour of approval of the therapy in April, although a verdict on the application was delayed for three months from an earlier action date of July 28 in order to give the agency more time to review the data.

"Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat," said Karen Midthun, the director of the FDA's Center for Biologics Evaluation and Research (CBER). 

"This approval provides patients and healthcare providers with a novel treatment for melanoma," she added.

In the pivotal OPTiM trial, 16% of subjects treated with Imlygic had a decrease in size of their skin and lymph node lesions, lasting for a minimum of six months, compared to just 2% of those receiving a comparator therapy (granulocyte macrophage colony stimulating factor; GM-CSF).

Amgen's drug was not able to improve overall survival or to have an effect on melanoma that has spread to the brain, bone, liver, lungs, or other internal organs, according to the FDA, but the palliative effects were considered significant enough to warrant approval.

Imlygic has also been recommended for approval in Europe by the Committee for Medicinal Products for Human Use (CHMP), so is on course to be available on both sides of the Atlantic in the coming months.

Amgen is also looking at combining the oncolytic virus therapy with Merck & Co's checkpoint inhibitor Keytruda (pembrolizumab) in head and neck cancer, and recently started phase I trials of the duo.

Amgen acquired the drug as part of its takeover of BioVex in 2011, valued at up to $1bn with $425m paid upfront. The drug is expected to be relatively minor product for the company, with peak sales less than $500m a year, although it represents a significant milestone in the development of oncolytic viruses as a therapeutic category.

Other companies working in this area include Oncolytics Biotech, Jennerex, Virttu Biologics, Genelux, DNAtrix and AstraZeneca (AZ) which entered the field via a collaboration between its Medimmune subsidiary and Omnis earlier this year.

Imlygic is not the first oncolytic virus to get regulatory approval, however. That distinction goes to Rigvir, a therapy for melanoma developed by Latvian scientists that was cleared in that country in 2004 and also got the go-ahead in Georgia earlier this year. 

China also approved an adenovirus-based therapy called Oncorine - developed by Shanghai Sunway Biotech - for head and neck cancer in 2005.

Article by
Phil Taylor

28th October 2015

From: Regulatory



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