FDA grants breakthrough therapy status to futibatinib for advanced cholangiocarcinoma
The FDA granted breakthrough therapy designation to futibatinib for the treatment of patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 gene rearrangements, according to a press release from the agent’s manufacturer.
Futibatinib (TAS-120, Taiho Oncology) — a covalently binding small-molecular inhibitor of FGFR— previously received orphan drug status for this indication. The agent is under investigation for the treatment of patients with advanced solid tumors with FGFR genetic aberrations who previously received chemotherapy or other therapies.
This decision was based on data from the phase 2 FOENIX-CCA2 study, scheduled for presentation at American Association for Cancer Research Annual Meeting this month.
“Patients living with locally advanced and metastatic cholangiocarcinoma, or bile duct cancer, currently have a poor prognosis, particularly since there is no standard treatment after the failure of first-line chemotherapy,” Martin J. Birkhofer, MD, senior vice president and chief medical officer of Taiho Oncology, Inc, said in the press release. “We are pleased that the FDA has recognized the potential benefit of futibatinib in previously treated [patients with cholangiocarcinoma]. We look forward to continued dialogue with FDA and other health authorities as we work toward global availability of futibatinib for [these] patients.”
Read more about