FDA warns of toxic effects of Onyx drug
BY MATTHEW PERRONE Associated Press
Tuesday, June 19, 2012
WASHINGTON — The toxic side effects
of an experimental cancer drug
from Onyx Pharmaceuticals may outweigh
its benefits for patients with a
type of blood cancer, federal health regulators
said Monday.
The Food and Drug Administration
warned that patients in a company study
of the drug had a high rate of heart and
lung side effects, some of which were
fatal. The FDA posted its review of
carfilzomib online ahead of a meeting
Wednesday, where its panel of cancer
experts will recommend whether the
drug should be approved.
Despite the negative tone of the review,
some analysts said they expect the
FDA’s panel of outside experts to take
a more favorable view. FDA panels are
mainly comprised of practicing physicians
from leading universities and hospitals.
BMO Capital Markets analyst Jim
Birchenough said he expects “panel
members to be more constructive toward
the carfilzomib data package.”
Birchenough recommended buying the
stock, in a note to investors.
Shares of Onyx Pharmaceuticals Inc.,
based in San Francisco, fell 71 cents to
$45.27 in midday trading after rising
as high as $46.99 earlier in the session.
They are near their 52-week high of
$47.80 in late April.
Onyx has asked the FDA to approve
carfilzomib as a treatment for patients
with advanced forms of multiple myeloma
whose disease has spread despite
treatment with other drugs.
Multiple myeloma affects plasma cells
in bone marrow. Over 50,000 people
have the disease in the U.S., and about
20,000 new cases are diagnosed every
year.
Onyx studied the drug in 266 patients
who had already been treated with two
other cancer drugs. About 22 percent
of patients studied responded to the
drug, with the typical patient surviving
slightly less than eight months after beginning
treatment. In its briefing, FDA
reviewers commented that the response
rate was so low “it may not provide an
advantage over available therapy.”
