FDAnews
www.fdanews.com/articles/175244-fda-seeks-additional-safety-efficacy-data-from-telestas-bladder-cancer-candidate

FDA Seeks Additional Safety, Efficacy Data from Telesta’s Bladder Cancer Candidate

February 8, 2016

Telesta Therapeutics has received a complete response letter from the FDA, informing the company that its BLA for Mycobacterium phlei cell wall-nucleic acid complex would need an additional Phase 3 clinical trial to adequately establish the candidate’s efficacy and safety.

The candidate — designed for the treatment of non-muscle-invasive bladder cancer — achieved an overall disease-free survival rate of 25 percent at one year and 19 percent at two years, according to the drugmaker.

Telesta Chief Operating Officer Donald Olds did not return a request for comment.