Home · Health · Sep 24 archive
FDA Okays New FGFR2 Inhibitor for Cholangiocarcinoma
Developing
In Short: The FDA has approved lirafugratinib (Lyrfigtu), a new FGFR2 inhibitor, for adults with previously treated unresectable, locally advanced, or metastatic cholangiocarcinoma that harbors a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement.
According to a press release from Elevar Therapeutics, lirafugratinib selectively targets FGFR2, distinguishing it from existing pan-FGFR inhibitors that broadly inhibit FGFR1, FGFR3, and/or FGFR4 in addition to FGFR2.
The approval was based on the single-arm phase 1/2 ReFocus trial involving 116 patients who were new to FGFR2 blockers after prior chemotherapy or chemoimmunotherapy.
Lirafugratinib joins two other FGFR2-targeted tyrosine kinase inhibitors already on the US market: pemigatinib and futibatinib.
In testing, lirafugratinib showed lower rates of adverse events commonly associated with non-selective FGFR inhibitors, such as hyperphosphatemia and diarrhea, at 20.7% and 21.6%, respectively.
What's still developing
- The FDA has approved lirafugratinib (Lyrfigtu, Elevar Therapeutics) for adults with previously treated unresectable, locally advanced, or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement.