FDA grants accelerated approval for Truseltiq to treat metastatic cholangiocarcinoma with an FGFR2 fusion - BridgeBio Pharma, QED Therapeutics and Helsinn Group.

 The announcement was made by BridgeBio Pharma through its affiliate QED Therapeutics and Helsinn Group. BridgeBio and Helsinn Group’s affiliate, Helsinn Therapeutics, will jointly handle commercialization in the U.S. and share U.S. profits and losses equally. Helsinn Group will handle marketing except for in China, Hong Kong, and Macau. BridgeBio will be eligible for tiered royalties as a percentage of adjusted net sales and payments reaching up to $2.45 billion More marketing applications are being reviewed in Australia and Canada under Project Orbis. Orbis is a program out of the FDA’s Oncology Center of Excellence that lets companies submit and review cancer drugs concurrently among participating international regulators. Truseltiq is an oral ATP-competitive, tyrosine kinase inhibitor of FGFR. CCA is a cancer of the liver bile ducts. It affects about 20,000 people in the U.S. and Europe annually and has a median five-year survival rate of 9%. FGFR2 genetic mutations are observed in 15% to 20% of the illness. Advanced, unresectable CCA is rare and aggressive with a poor prognosis.