Compass Therapeutics and AstraZeneca have both provided updates to their respective clinical therapeutic programs targeting biliary tract cancers.
U.S. Food and Drug Administration Accepts for Priority Review Taiho Oncology’s New Drug Application for Futibatinib for Cholangiocarcinoma
Accepted NDA, Cholangiocarcinoma, Clinical Trials, FDA/Regulatory, FGFR2 gene, Gene fusions, New Drug Applications, PDUFA, Priority Review Status, R&D, Small-Molecule InhibitorsTaiho Oncology Inc. and Taiho Pharmaceutical Co. Ltd. announced that the U.S. Food and Drug Administration accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 gene rearrangements, including gene fusions.
AstraZeneca shared positive results from the company’s TOPAZ-1 Phase III trial on Imfinzi (durvalumab) in increasing the chances for survival in advanced biliary tract cancer patients when combined with standard-of-care chemotherapy regimens.
The U.S. Food and Drug Administration approved Truseltiq (infigratinib) under the accelerated approval program for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement.