FDA accepts BridgeBio/QED's infigratinib application for bile duct cancer

 

• The FDA accepts for review BridgeBio Pharma (NASDAQ:BBIO) and affiliate QED Therapeutics' New Drug Application (NDA) for infigratinib for the first-line treatment of advanced/metastatic cholangiocarcinoma (bile duct cancer) with FGFR2 gene fusions or translocations.
• Infigratinib a lead drug candidate is an orally administered, FGFR1-3 selective tyrosine kinase inhibitor.
• The NDA has been granted priority review designation and is being reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients.
• Additionally, BridgeBio will submit for review in Australia and Canada under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.
• BBIO's NDA for fosdenopterin in molybdenum cofactor deficiency (MoCD) Type A was accepted in September 2020.
• https://seekingalpha.com/news/3640300-fda-accepts-bridgebio-pharma-qeds-infigratinib-application-for-bile-duct-cancer