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Home » Kinnate Biopharma Gets Fast Track Status for Bile Duct Cancer Candidate
Kinnate Biopharma Gets Fast Track Status for Bile Duct Cancer Candidate
Kinnate Biopharma received Fast Track status for its KIN-3248 drug, an investigational candidate for the treatment of patients with unresectable, locally advanced or metastatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other alterations and who received at least one prior systemic therapy.
KIN-3248 is a pan-FGFR inhibitor that addresses alterations related to FGFR2 and FGFR3, alterations which can lead to resistance to current FGFR-targeted therapies.
The investigational drug has shown promise in preclinical studies, demonstrating inhibitory activity across a wide range of relevant mutations.
Fast Track status allows a company to receive more frequent interactions with the FDA and could lead to Priority Review and Accelerated Approval.
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