Biologic Tx BLA Accepted for Bladder Cancer

Telesta Therapeutics announced that the Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for MCNA as a therapeutic alternative to surgery in high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy.

The FDA has set February 27, 2016 as its review goal date for MCNA’s potential approval.

RELATED: Circulating Tumor Cell Assays May Play Role in Managing Bladder CA

MCNA is a biologic therapy derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects.

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