Telesta's Bladder Cancer Therapy To Face Questions On Evidence Adequacy

25 Sep 2015

Canadian firm will try to persuade two FDA advisory committees that 129-patient, single-arm, Phase III study supports approval of MCNA for non-muscle invasive bladder cancer.

Two FDA advisory committees will meet Nov. 18 to consider whether efficacy and safety data from a small, one-arm, Phase III trial are adequate to support approval of Telesta Therapeutics Inc.'s novel and complex biologic treatment for bladder cancer.

FDA's Cellular, Tissue and Gene Therapies and the Oncologic Drugs advisory committees will discuss the safety and efficacy of Mycobacterium...