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 The agency also approved the drug as a single agent for patients
with relapsed or refractory multiple myeloma who have received one
or more previous treatments.
The decision converts to full approval an initial accelerated
approval given to the drug in 2012 as a single agent, Amgen said.
Accelerated approval is given to drugs based on a surrogate
endpoint, such as a radiographic image or laboratory measure, that
is thought to predict a clinical benefit.
Companies are required to conduct studies to confirm the anticipated
benefit. If a confirmatory trial shows the drug does confer such a
benefit, the FDA grants full approval for the drug.
A trial testing Kyprolis combined with the drug dexamethasone
doubled the length of time before the disease progressed compared
with a rival drug, Velcade, plus dexamethasone.
Amgen said the agency approved Kyprolis in combination with
dexamethasone or with the drug lenalidomide plus dexamethasone for
relapsed or refractory patients. It approved the drug as a single
agent for patients with relapsed or refractory disease who have
received one or more treatments.
[to top of second column] |
(Reporting by Toni Clarke in Washington; Editing by Bill Rigby)
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