FDA accelerated appro for infigratinib in metastatic cholangiocarcinoma

The US Food and Drug Administration has granted accelerated approval to Truseltiq (infigratinib), a kinase inhibitor for adults with previously treated, unresectable locally-advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

The drug was developed by USA-based BridgeBio Pharma’s (Nasdaq: BBIO) affiliate QED Therapeutics. BridgeBio’s shares closed up 2% at $59.20 following the announcement on Friday

“This is an important milestone for patients diagnosed with FGFR2-fusion-driven cholangiocarcinoma who have recurred after first-line therapy and are in need of targeted options for further treatment,” said Dr Susan Moran, chief medical officer for QED. “Based on the efficacy seen to date, our team believes infigratinib possesses promise for a range of FGFR-driven conditions, including other cancers. We will continue to evaluate its safety and efficacy in these areas of unmet need,” she added.