Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.OncoMed Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration's Office of Orphan Products Development (OOPD) for tarextumab (anti-Notch 2/3, OMP-59R5) to treat both pancreatic cancer and small cell lung cancer.
Subscribe to our email newsletter
Tarextumab is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors.
Currently, the company is enrolling patients in a randomized Phase II trial of tarextumab with gemcitabine plus Abraxane (paclitaxel protein-bound particles for injectable suspension) in first-line advanced pancreatic cancer patients.
OncoMed chairman and chief executive officer Paul Hastings said: "We are excited to receive two separate orphan drug designations for tarextumab for the treatment of pancreatic and small cell lung cancer."
Earlier this month, the company had reported positive clinical and biomarker data from its Phase Ib trial of tarextumab in combination with standard of care in pancreatic cancer.
In this trial, tarextumab was well tolerated with manageable side effects and the three drug combination achieved an overall clinical benefit rate of 73%.