Arcus Biosciences' Quemliclustat Gets Orphan Drug Status For Pancreatic Cancer

(RTTNews) - Arcus Biosciences, Inc. (RCUS) Thursday said that its quemliclustat was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. Orphan drug designation qualifies for several benefits including tax credits for qualified clinical trials, exemption from user fees including New Drug Application (NDA), and a potential seven years of market exclusivity after approval.

A registrational Phase 3 study to evaluate quemliclustat plus gemcitabine/nab-paclitaxel chemotherapy versus gemcitabine/nab-paclitaxel chemotherapy alone in patients with pancreatic ductal adenocarcinoma (PDAC) is underway.