Lyrfigtu Gains FDA Approval for Previously Treated Cholangiocarcinoma with FGFR2 Mutation
The once-daily pill showed a 46% response rate in a 116-patient trial and requires genomic testing plus regular eye exams.
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7 Articles
Lyrfigtu gains FDA approval for previously treated cholangiocarcinoma with FGFR2 mutation
The FDA approved lirafugratinib — a kinase inhibitor — for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma.The indication for lirafugratinib (Lyrfigtu, Elevar Therapeutics) applies to patients with a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement.
Cristinareal companies 'Lyrfigtu', for cholangiocarcinoma South Korean biotechnology has just crossed a regulatory threshold with the approval in the United States of Lyrfigtu -lirafugratinib-, from HLB Group. The FDA has given green light to the oral inhibitor of FGFR2 for adults with unresectable, locally advanced or metastatic cholangiocarcinoma, previously treated, whose tumors present a fusion or other rearrangement of FGFR2. The importance…
Elevar wins first FDA approval with second-line drug for bile duct cancer
The FDA approved Elevar Therapeutics’ Lyrfigtu as a second-line treatment option for certain patients with bile duct cancer, which is diagnosed in about 8,000 Americans each year. Wednesday's green light for Lyrfigtu was based on ...
Elevar Therapeutics Announces FDA Approval of Lyrfigtu (Lirafugratinib) as Second-line Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement Treatment Option
Lyrfigtu demonstrated a confirmed ORR of 46% and mDOR of 11.8 months, with a predictable and manageable safety
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