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 The drug, to be sold under the brand name Imlygic, is an engineered
version of a herpes virus that kills cancer cells when injected
directly into cancerous lesions on or under the skin, destroying
them from the inside, while also priming the immune system to attack
the disease.
The Food and Drug Administration said Imlygic, known chemically as
talimogene laherparepvec, or T-Vec, is the first oncolytic virus
therapy to be approved in the United States. It is awaiting European
approval after receiving a favorable recommendation from regulators
there.
Amgen said it expects the average cost of Imlygic therapy to be
about $65,000, and that it will be available to U.S. patients within
a week. The company said it is studying the drug in combination with
other immunotherapies in advanced melanoma and other solid tumor
cancers.
This represents the sixth U.S. approval for Amgen in the last 12
months, including another cancer drug, Blincyto, and its potent new
cholesterol fighter Repatha.
The U.S. Imlygic approval was widely expected after an advisory
panel to the FDA in April voted 22-1 to support its approval,
despite a lack of definitive overall survival data on the treatment.
"T-Vec represents an important milestone in using viruses as the
vehicle to stimulate immune response and fight cancer," Tim Turnham,
executive director of the Melanoma Research Foundation, said in a
statement. "Despite remarkable advances in the past four years, the
majority of patients with metastatic melanoma still die from this
cancer."
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Wall Street analysts expect the drug to be a relatively small
product for the world's largest biotechnology company. Thomson
Reuters Cortellis forecast peak sales of $387.5 million by 2020.
The Imlygic label contains warnings that it should not be used by
pregnant patients or anyone with a compromised immune system. It
also notes that accidental exposure to the drug could lead to
transmission of herpetic infection.
Amgen shares rose just over 1 percent to $163.50 in extended trading
from a Nasdaq close at $161.98.
(Reporting by Bill Berkot in New York and Samantha Kareen Nair and
Natalie Grover in Bengaluru; Editing by Anil D'Silva and Matthew
Lewis)
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