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FDA grants priority review to MCNA for nonmuscle-invasive bladder cancer
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The FDA granted priority review to MCNA for patients with high-risk nonmuscle-invasive bladder cancer, according to a press release from the drug’s manufacturer.
MCNA (mycobacterium phlei cell wall-nucleic acid complex, Telesta Therapeutics) — a biologic therapy derived from the cell wall fractionation of non-pathogenic bacteria — is intended for patients with bladder cancer who are refractory to or who relapsed on front-line therapy with a therapeutic alternative to surgery.
The drug is intended to be delivered by urologists and urology nurses as a sterile suspension for intravesical administration, following the same dosing regimen as first-line bacillus Calmette-Guérin therapy.
The FDA set a priority review target action date of Feb. 27, 2016. The FDA accepted Telesta’s Biologics License Application (BLA) for MCNA and will form an advisory committee to discuss the BLA, according to the press release.
“Today is a historic day for Telesta Therapeutics and for all of our staff and collaborators who have worked so diligently to advance our new treatment for nonmuscle-invasive bladder cancer towards potential regulatory approval early next year,” Michael Berendt, PhD, CEO of Telesta, said in a press release. “While we recognize that the FDA must complete its full review of our BLA filing before rendering its ultimate decision, we are working extremely hard, at all levels, to prepare for commercial launch in the U.S."