FDA grants priority review to infigratinib for cholangiocarcinoma
The FDA granted priority review designation to infigratinib for the treatment of cholangiocarcinoma, according to the agent’s manufacturer.
The agency will review the application under its Real-Time Oncology Review pilot program, designed to accelerate the delivery of effective and safe cancer treatments to patients.
Infigratinib (BridgeBio Pharma/QED Therapeutics) is an oral FGFR1-3 selective inhibitor in development for people with FGFR-driven conditions, including cholangiocarcinoma, urothelial carcinoma and achondroplasia.
Approximately 20,000 people in the United States are diagnosed each year with cholangiocarcinoma, an often-fatal cancer of the bile ducts.
An estimated 15% to 20% of patients have FGFR2 genetic aberrations. Treatment options for these patients are limited, and only about 9% survive 5 years.
“We want to thank the patients, families, scientists, physicians and all others involved who helped us move this new drug application forward,” Neil Kumar, PhD, CEO and founder of BridgeBio, said in a company-issued press release. “We believe that every minute counts for patients and their families, and we are eager to help as many people suffering from cholangiocarcinoma as possible — as quickly as possible.”
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