On December 1, 2014 Momenta Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of necuparanib, the Company’s novel oncology drug candidate, as a first-line treatment in combination with Abraxane and gemcitabine in patients with metastatic pancreatic cancer (Press release Momenta Pharmaceuticals, DEC 1, 2014, View Source [SID:1234501038]). Momenta recently announced the successful completion of Part A of the Phase 1/2 study and has initiated the Part B (Phase 2 proof-of-concept) study.

The FDA’s Fast Track Drug Development Program is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. This designation allows for companies to interact with the FDA review team frequently to discuss issues such as study design, extent of safety data required to support approval, the structure and content of an NDA, and other critical issues. In addition, such a product could be eligible for accelerated approval and/or priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission. If the FDA determines, after preliminary evaluation of clinical data submitted by a sponsor, that a Fast Track product may be effective, the Agency may also consider reviewing portions of a marketing application before the sponsor submits the complete application.

“Receipt of Fast Track designation from the FDA further supports our belief in the potential of necuparanib to enhance overall survival rates in patients with metastatic pancreatic cancer, a disease for which there are very limited treatment options,” said Jim Roach, MD, Chief Medical Officer of Momenta Pharmaceuticals. “We look forward to taking full advantage of the opportunities that Fast Track designation allows in order to maximize the possibility of an accelerated path to approval.”

In October 2014, Momenta completed the Part A dose escalation component of the Phase 1/2 clinical trial evaluating necuparanib in combination with Abraxane and gemcitabine in patients with advanced metastatic pancreatic cancer, and reported positive top-line data. Part B of the Phase 1/2 trial, currently underway, is a randomized, controlled, proof-of-concept study to evaluate the antitumor activity of necuparanib in combination with Abraxane plus gemcitabine, versus Abraxane plus gemcitabine alone. Momenta expects data from Part B to be available in the first half of 2017.