FDAapproves futibatinib, to be used for patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma, through its accelerated approval program. OncTwitter MedTwitter
that futibatinib covalently binds to FGFR2 and inhibits the signaling pathway. The other approved FGFR inhibitors are reversible ATP-competitive inhibitors.As a whole, cholangiocarcinoma is an aggressive cancer of the bile ducts. It is diagnosed in approximately 8000 individuals each year in the United States, the company noted.
These cases include both intrahepatic and extrahepatic forms of the disease. Approximately 20% of patients diagnosed with cholangiocarcinoma have the intrahepatic form of the disease. Among these 20%, approximately 10% to 16% of patients have FGFR2 gene rearrangements, including fusions, which promote tumor proliferation.
Futibatinib is"a key example of the potential of precision medicine in iCCA [intrahepatic cholangiocarcinoma] and represents another advance in the treatment of this rare and challenging disease," said medical oncologist Lipika Goyal, MD, MPhil, of the Massachusetts General Hospital Cancer Center and lead investigator of the pivotal study that supported the approval.
"I am encouraged that treatment options continue to expand and evolve for this disease through the dedicated efforts of many over several years," she commented in the company’s press release.
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