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Arcus Biosciences' Investigational Pancreatic Cancer Treatment Gets US FDA Orphan Drug Status
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Arcus Biosciences' Investigational Pancreatic Cancer Treatment Gets US FDA Orphan Drug Status
Jul 10, 2025 6:23 AM

09:10 AM EDT, 07/10/2025 (MT Newswires) -- Arcus Biosciences ( RCUS ) said Thursday the US Food and Drug Administration has granted orphan drug designation to its investigational therapy quemliclustat for the treatment of pancreatic cancer.

The designation qualifies backers of the small molecule inhibitor for tax credits, fee exemptions and prolonged market exclusivity, the company said.

In a previous study, a 100 milligram dose of the therapy resulted in a median overall survival of 15.7 months, exceeding the historical benchmark for chemotherapy alone, the company said.

The company added that it has initiatied a 610-patient phase 3 study to evaluate quemliclustat plus chemotherapy versus chemotherapy, a trial expected to finish enrollment this year.

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