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Infigratinib, a selective oral FGFR1–3 tyrosine kinase inhibitor, has demonstrated clinical efficacy in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 alterations. It received FDA breakthrough therapy designation for achondroplasia and is currently being evaluated in Phase 2/Phase 3 studies for skeletal dysplasias including achondroplasia and hypochondroplasia. An NDA was submitted to the FDA for second-line cholangiocarcinoma in 2020; first approval occurred May 28, 2021.
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