FDA’s (U.S.) Fast Track Status to Ovarian Cancer Drug TPIV 500 (200)

Oncology Times
 

Monday, February 8, 2016

 

FDA’s Fast Track Status to Ovarian Cancer Drug TPIV 500 

The U.S. Food and Drug Administration has granted Fast Track designation to the multiple-epitope Folate Receptor Alpha Peptide Vaccine (TPIV 200) with GM-CSF adjuvant for maintenance therapy in patients with platinum-sensitive advanced ovarian cancer whose disease is stable or who have had a partial response following completion of standard of care chemotherapy.
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 FDA had granted orphan drug designation to TPIV 200 for the same indication late last year.

A Phase II trial for TPIV 200 is being planned, according to a news release from the drug company developing the agent, TapImmune Inc.