First-line bladder cancer therapy receives fast track designation

March 13, 2008

The FDA has indicated that a new therapy for first-line nonmuscle-invasive bladder cancer meets the criteria for fast track designation.

The FDA has indicated that a new therapy for first-line nonmuscle-invasive bladder cancer meets the criteria for fast track designation.

A phase III clinical trial comparing the mycobacterial cell wall-DNA complex (MCC [Urocidin]) to the current standard therapy in patients with nonmuscle-invasive bladder cancer at high risk of recurrence or progression is scheduled to begin later this year. The study aims to demonstrate non-inferior efficacy with respect to disease-free survival and fewer toxicities than the current therapy, according to the drug’s manufacturer, Bioniche Life Sciences Inc.

“This is an important milestone for our phase III clinical development program with Urocidin,” said Graeme McRae, of Bioniche. “It highlights the need for a safer and more effective therapy for first-line bladder cancer patients. The FDA clearly recognizes that the current approved therapy is less than satisfactory and wishes to expedite the introduction of new therapies.”

The phase III study currently plans to enroll approximately 800 patients in North America, Australia, and Europe, and is a double-blind, randomized study. It will compare MCC to bacillus Calmette-Guerin (BCG [TheraCys, TICE BCG]), the standard treatment for patients with nonmuscle-invasive bladder cancer at high risk of recurrence or progression.