NEW YORK – BridgeBio Pharma subsidiary QED Therapeutics said on Wednesday that the US Food and Drug Administration accepted its new drug application for infigratinib to treat patients with FGFR-altered bile duct cancer.
The FDA also granted the NDA priority review, and the drug will be reviewed under the agency's Real-Time Oncology Review pilot program, which was designed to expedite cancer treatment approvals. BridgeBio will also submit the drug for review in Australia and Canada through the FDA's Project Orbis, which allows concurrent review of cancer drugs among some international regulators.
As part of the application, QED will submit data from a Phase III clinical trial, in which up to 384 patients with FGFR2 fusion-positive cholangiocarcinoma will be randomized to receive infigratinib or chemotherapy as a first-line option.
In an earlier Phase II study, infigratinib showed an overall response rate of 27 percent in bile duct cancer patients who had FGFR2 fusion-positive tumors and had progressed on chemotherapy. About a quarter of the patients in that trial had a partial response to the treatment, though none had a complete response, while the median progression-free survival was 6.8 months and median overall survival was more than a year.
Last month, LianBio said it was cleared to begin a Phase III trial of infigratinib in bile duct cancer with FGFR2 gene fusions in China. LianBio is responsible for developing and commercializing the drug in mainland China, Hong Kong, and Macau.