FDA grants fast track, orphan drug designations to infigratinib for cholangiocarcinoma

The FDA granted fast track designation to infigratinib for first-line treatment of patients with unresectable advanced or metastatic cholangiocarcinoma who harbor FGFR2 gene fusions or translocations, according to the agent’s manufacturer.The agency also granted orphan drug designation to infigratinib (BridgeBio Pharma/QED Therapeutics) for the treatment of cholangiocarcinoma.Cholangiocarcinoma — a cancer of the bile ducts — affects approximately 20,000 people in the United States and Europe each year. An estimated 15% to 20% of patients have FGFR2 genetic aberrations.Read More

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