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