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.
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.