Shots:
The US FDA has approved Lyrfigtu for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement; US availability is expected by Q4’26
In the P-I/II (ReFocus) trial, Lyrfigtu showed a cORR of 46%, an mDoR of 11.8mos., & 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), with a predictable and manageable safety…
Shots:
The US FDA has received an NDA of lirafugratinib for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement
NDA was backed by the P-I/II (ReFocus) trial, which showed 46.5% ORR, 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), 12mos. OS of 74.6% (mOS: 22.8mos.), DCR of 96.5%, & mDoR of 11.8mos.,…

