September 29, 2021
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FDA grants fast track designation to acelarin for biliary tract cancer
The FDA granted fast track designation to acelarin for treatment of biliary tract cancer.
Acelarin (NUC-1031, NuCana) is a chemical modification of gemcitabine.
A phase 3 trial is underway to evaluate the agent as first-line treatment for patients with advanced biliary tract cancer.
Researchers have enrolled 418 evaluable patients, and the first interim analysis is expected in the first half of 2022.
“We are very pleased that the FDA recognizes the potential of Acelarin to address the significant unmet need of patients with biliary tract cancer,” Hugh S. Griffith, NuCana’s founder and CEO, said in a company-issued press release.
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