* One of several new drugs for most deadly form of skin
cancer
* Has also been recommended by a U.S. advisory panel
(Adds details on product, comment from company, outside expert)
By Ben Hirschler
LONDON, Oct 23 (Reuters) - A first-in-class drug from Amgen
AMGN.O based on a tumour-killing virus was given a green light
by European regulators on Friday, paving the way for its
approval within a couple of months.
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 tumours 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 tumours 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 ONC.TO , SillaJen, Targovax TRVX.NFF and
Genelux.
(Editing by Jason Neely and Mark Potter)