Spectrum bladder cancer
drug not effective: U.S. FDA panel
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[September 15, 2016]
By Toni Clarke
(Reuters) - Spectrum Pharmaceuticals Inc's
experimental bladder cancer treatment apaziquone is not effective in
delaying the time to recurrence of the disease, an advisory committee to
the U.S. Food and Drug Administration concluded on Wednesday.
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Spectrum's shares fell 6.2 percent to $5.15.
The committee, which convened to advise the FDA on whether to
approve the drug, voted unanimously that the treatment has no more
effect on the disease than a placebo over a two-year period.
The FDA is not obliged to follow the advice of its advisory
committees but typically does so. The agency is scheduled to make
its decision by Dec. 11.
Apaziquone is inserted directly into the bladder following surgery
to remove tumors. In 2012, two late-stage clinical trials failed to
meet their main goal.
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The company subsequently initiated a new late-stage trial which it
said incorporated input from the FDA and included pooled data from
its two previous trials. The pooled data, as opposed to data from
individual trials, showed a reduction in disease recurrence over two
years.
The new trial protocol called for patients to be given either one
instillation of the drug, or two, or a placebo. In the previous
late-stage trials all patients received just one installation or a
placebo.
Apaziquone is activated by enzymes that are over-expressed in
bladder cancer cells.
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Most bladder cancers are treated with surgery, either alone or with
other treatments. Surgery can often remove early stage bladder
tumors, but new tumors frequently form in other parts of the
bladder. Some 80 percent of patients experience a recurrence within
5 years, many within two years.
Removing the entire bladder avoids this but the procedure can have a
significant impact on a patient's quality of life since new methods
are needed to remove urine from the body. This typically requires
reconstructive surgery to create a new receptacle, inside or outside
the body, that the patient has to drain.
(Reporting by Toni Clarke in Washington; Editing by Alan Crosby)
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