FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

NuCana Nabs Orphan Status for Biliary Tract Cancer Drug

June 24, 2019

NuCana’s investigational drug Acelarin (NUC-1031) has earned an orphan drug designation from the FDA for treating biliary tract cancer.

The United Kingdom-based drugmaker said its Phase Ib study of the drug in combination with cisplatin showed an approximate doubling of the response rate compared with combination treatment with gemcitabine and cisplatin.

Biliary tract cancer develops in the bile duct system, which moves bile to the small intestine. Approximately 12,000 new cases of the cancer are diagnosed in the U.S. each year.

NuCana said it’s on track to open a Phase 3 study of Acelarin in combination with cisplatin as a front-line treatment for patients with advanced biliary tract cancer in 2019.

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