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news.The FDA has granted fast track designation to Bioniche Life Sciences' Urocidin for the treatment of non-muscle invasive bladder cancer in patients who are unresponsive to the current standard therapy.
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The standard chemotherapy for the condition is bacillus calmette-guerin (BCG), a live, attenuated strain of mycobacterium bovis, a therapy that is often associated with treatment-limiting side effects.
In February the FDA approved the company’s 105 patient North American phase III clinical trial with Urocidin in the treatment of this (unresponsive to BCG) patient population.
Fast Track designation means that, when data from the phase III program becomes available, the company could expect an expedited review of its biologics licensing application for Urocidin.
“A large number of patients don’t respond to BCG – approximately 35% – and have not previously had a satisfactory alternative treatment beyond bladder removal, an invasive and life-altering surgery. This designation gives us great confidence that Urocidin will be available to uro-oncologists for their refractory patients at the earliest possible opportunity,” said Graeme McRae, president & CEO of Bioniche.
The trial in patients unresponsive to BCG is one of two trials in Bioniche’s phase III program with Urocidin. The second will involve approximately 630 patients and will compare Urocidin to BCG as first-line therapy in non-muscle invasive bladder cancer at high risk of recurrence or progression.