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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.

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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.


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.