The Oncologic
Drugs Advisory Committee, which is part of the U.S. Food and
Drug Administration, has voted that
Spectrum Pharmaceuticals' Qapzola has not displayed considerable
indication of a more effective treatment compared to placebo for immediate
intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer.
Qapzola’s recommendation from the committee is not bound to
the FDA. The FDA does, however, make the final decision when it comes to an
approval for the drug.
The medication’s Prescription Drug User Fee Act date was Dec. 11.
Qapzola receives setback from FDA committee
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