Spectrum's Qapzola turned down by FDA
- Spectrum Pharmaceuticals' bladder cancer drug, Qapzola (apaziquone), was turned down by the U.S. Food and Drug Administration ahead of its Dec. 11, Prescription Drug User Fee Act goal date.
- Following a meeting last week with the FDA, the company is looking at a new smaller study to replace the terminated Phase 3 trial in hopes of filing the drug again.
- Bladder cancer is the fifth most common cancer in the U.S., with 74,000 new cases expected in 2015.
In a Form 8-K issued last week, Spectrum Pharmaceuticals said that it had "received a Complete Response Letter from the FDA to the New Drug Application for Qapzola (apaziquone for intravesical instillation)."
The filing noted that the company met with the agency on Nov. 15, and that based on the discussions, the company is evaluating a new smaller study that would "replace the ongoing Phase 3 program in which enrollment has been stopped."
In September 2016, the FDA Oncologic Drugs Advisory Committee (ODAC) voted that intravesical administration of Qapzola (apaziquone) post-transurethral resection of bladder tumors did not show enough of a treatment effect over placebo in patients with non-muscle invasive bladder cancer (NMIBC).
The advisory committee vote was 14 to 0; the FDA is not required to follow the advice of the committees, but often does. The expects were deterred by the two Phase 2 trials that both missed the primary endpoint, a statistically significant reduction in disease recurrence at two years compared with placebo. The company was reported to be carrying out another Phase 3 to look at the impact of timing of treatment on outcomes, and the effect of a second apaziquone dose.
Bladder cancer is currently a busy area, with the checkpoint inhibitors from Merck & Co., Roche and Bristol-Myers Squibb currently battling for a place in the market. Apaziquone, by having a different mechanism of action, and local delivery, could still find a space in the market, but this delay in approval could set its prospects back.
- Securities and Exchange Commission Filing
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