Taiho Oncology Reports the US FDA’s Acceptance of NDA for Priority Review of Futibatinib for the Treatment of Cholangiocarcinoma
Shots:
- The NDA was based on the P-IIb (FOENIX-CCA2) trial to evaluate Futibatinib (20mg, qd) in 103 patients with LA or metastatic unresectable intrahepatic CCA, harboring FGFR2 gene rearrangements including fusions who had received one or more prior lines of systemic therapy
- The 1EPs of the trial was an ORR (41.7%) as assessed by independent central review & the 2EPs include m-DoR (9.7mos.) with 72% of responses ≥6mos.
- Futibatinib is an oral, potent, selective, and irreversible small-molecule inhibitor of FGFR1, 2, 3 & 4 & has received the BTD from the US FDA for the treatment of patients with LA or metastatic CCA in 2021. The US FDA has assigned a PDUFA date on Sept 30, 2022
Ref: PR Newswire | Image: Twitter
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