The decision is a further milestone for a technology that has long fascinated scientists but has previously proved difficult to harness.
The European Medicines Agency (EMA) said its experts had recommended approval of Imlygic, also known as talimogene laherparepvec or “T-Vec”, for treating melanoma, making it another option among several new drugs for the most deadly form of skin cancer.
“Viral immunotherapy represents a completely new way of treating cancer, so it’s extremely exciting to see T-Vec become the first treatment of this type to gain the green light from European regulators,” said Paul Workman, Chief Executive of The Institute of Cancer Research, London.
The drug is recommended for treating melanoma that cannot be removed by surgery and has spread without affecting internal organs.
Imlygic uses a herpes simplex virus, the type that causes cold sores, which has been modified to only infect cancer cells. It is injected directly into tumors where it replicates and causes cancer cells to rupture and die, also stimulating a system-wide immune response.
Until three years ago, chemotherapy was the only available treatment for patients whose melanoma had spread. But recently there have been a number of new treatments, including immunotherapies, BRAF V600 inhibitors and MEK inhibitors.
Despite this progress, the EMA said there was still a need for new treatments with acceptable safety profiles to continue to improve the outlook for patients.
Amgen said melanoma remained one of the most difficult-to-treat cancers, often requiring the use of multiple treatments.
In clinical tests, Imlygic has shrunk tumors but it has not yet been shown to extend lives.
“Exploratory analysis in these patients suggested improvements in survival in patients treated with Imlygic, however this is not yet fully clear,” the EMA said. “Imlygic has also not been compared with other recently approved medicines for melanoma, which have shown beneficial effects on survival.”
Amgen’s product was recommended by an advisory panel to the U.S. Food and Drug Administration in April and the U.S. agency is due to give its verdict on whether to approve the medicine by Oct. 27.
Amgen secured rights to Imlygic after buying BioVex for up to $1 billion in 2011, marking a notable bet on so-called oncolytic virus technology in the wake of earlier disappointments. Onyx Pharmaceuticals had a big setback in the field in 2003 with a product called ONYX-015, a modified common cold virus.
Other companies working on cancer-fighting viruses include Oncolytics Biotech, SillaJen, Targovax and Genelux.
Source: Reuters Health