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., where 76.2% of responses lasted >6mos.
- Also, Elevar is advancing lirafugratinib for other FGFR2-altered solid tumors after acquiring global rights in Dec 2024 from Relay Therapeutics, with the FDA advising an NDA first for FGFR2-driven CCA followed by an sNDA for other FGFR2-altered cancers
Ref: Globenewswire | Image: Elevar | Press Release
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