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The Food and Drug Administration has granted Orphan Drug status to demcizumab (anti-DLL4, OMP-21M18) for the treatment of pancreatic cancer.

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The FDA's Orphan Drug program provides that designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the United States. The designation provides eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees.


Demcizumab is a humanized monoclonal antibody that inhibits Delta-Like Ligand 4 (DLL4) in the Notch signaling pathway. A news release from the drug's manufacturer, OncoMed, notes that two Phase Ib combination trials of the agent are ongoing: The first, in combination with standard-of-care gemcitabine and nab-paclitaxel in first-line advanced pancreatic cancer patients; and the second, in combination with standard-of-care carboplatin and pemetrexed in patients with advanced non-small cell lung cancer (NSCLC). In addition, a Phase Ib/II trial of demcizumab and paclitaxel in patients with platinum-resistant ovarian cancer, is being conducted at the University of Texas MD Anderson Cancer Center.


Interim data from the demcizumab clinical study in pancreatic patients were presented in January at the Gastrointestinal Cancers Symposium, and data from the ongoing demcizumab NSCLC Phase Ib study were reported at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics last October.


Information from OncoMed notes that demcizumab is part of their collaboration with Celgene Corporation, and that the expectation is to start a randomized Phase II study of the agent later this year in combination with nab-paclitaxel and gemcitabine in first-line pancreatic cancer.


Data from the American Cancer Society show that the incidence of pancreatic cancer has been increasing in recent years, and it is now the fourth-leading cause of cancer-related deaths.