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The Food and Drug Administration has granted Fast-Track status to DPX-Survivac as maintenance therapy for patients with advanced ovarian, fallopian tube, and peritoneal cancer who have no measurable disease following surgery and front-line platinum/taxane chemotherapy to improve their progression-free survival. DPX-Survivac, made by Immunovaccine Inc., is a novel cancer immune therapy that stimulates the immune system to produce T cell responses targeting the tumor associated antigen survivin.

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The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The designation permits the drug developer the opportunity to submit sections of an NDA on a rolling basis as data become available, allowing the FDA to review those materials on a rolling basis as well.


The design of a large randomized Phase II trial in ovarian cancer is being finalized, following reports of positive results from earlier Phase I trials for the drug in patients with ovarian cancer, according to a news release from the manufacturer.