Infigratinib (BGJ398) has been granted Fast Track Designation by the FDA for the treatment of cholangiocarcinoma in adult patients with first-line advanced or metastatic disease, according to a press release from QED Therapeutics, a subsidiary of BridgeBio Pharma, Inc, and developer of infigratinib.
“We believe that Fast Track and Orphan Drug Designations for infigratinib for the treatment of cholangiocarcinoma underscores the need for new, targeted treatments for genetically-driven subsets of this cancer, particularly for adults with first-line advanced or metastatic cholangiocarcinoma,” said Susan Moran, MD, MSCE, chief medical officer for QED Therapeutics. “Fast Track Designation will enhance our interaction with the FDA on our first-line advanced or metastatic cholangiocarcinoma program and may help us get this medicine to patients more quickly.”
Infigratinib is currently under investigation in the phase III PROOF trial, which has begun dosing patients with advanced cholangiocarcinoma with FGFR2 gene fusions or translocations. PROOF is a multicenter, open-label, randomized, controlled phase III study of infigratinib versus gemcitabine with cisplatin.
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