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Future of Bladder Cancer Drugs Unknown After Rejections and Discontinuation of Meds

November 28, 2016

The FDA rejected Spectrum Pharmaceuticals’ Qapzola, a treatment for non-muscle invasive bladder cancer, the company said following receipt of a CRL.

Spectrum plans to continue studying the drug and is considering a smaller sample size for a future trial, after meeting with the FDA on a strategy for the drug’s further development. The company added that it has stopped enrollment in its ongoing Phase III trials of Qapzola.

In September, an FDA advisory committee voted unanimously against the drug’s approval, citing the candidate’s failure to meet the primary endpoint of preventing recurrence in two Phase III trials.

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