The Food and Drug Administration has granted Fast Track status to necuparanib (formerly M402) as a first-line therapy for use in combination with Abraxane (paclitaxel) and gemcitabine for the treatment of patients with metastatic pancreatic cancer. Necuparanib, marketed by Momenta Pharmaceuticals, is a novel drug engineered from unfractionated heparin to have significantly reduced anticoagulant activity while preserving relevant antitumor properties associated with heparins so that higher doses could potentially increase these antitumor effects.
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.
Necuparanib previously received Orphan Drug designation for the treatment of patients with pancreatic cancer earlier this year. Since then the Part A dose escalation component of the Phase 1/2 clinical trial evaluating the drug in combination with Abraxane and gemcitabine in patients with advanced metastatic pancreatic cancer has been completed.
Part B of the trial is underway, which 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. This data is expected to be available in 2017.