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The FDA plans to decide on whether to approve futibatinib for the treatment of patients with previously treated, locally advanced or metastatic cholangiocarcinoma that harbors a certain genetic mutation by September.
The Food and Drug Administration (FDA) has granted priority review to an application seeking approval for futibatinib for the treatment of previously treated locally advanced or metastatic cholangiocarcinoma, a cancer of the bile ducts of the liver, that harbors FGFR2 genetic mutations, according to a press release.
Of those diagnosed with cholangiocarcinoma, according to the release, 10% to 16% of have tumors that express this particular genetic mutation.
“Given the lack of an accepted standard chemotherapy following the failure of first-line treatment, futibatinib could represent a significant opportunity for a targeted therapy in this subset of patients with (cholangiocarcinoma), which has driven our pursuit with this investigational compound,” Volker Wacheck, vice president of Clinical Development at Taiho Oncology, said in the release. “We look forward to working with the FDA as they consider the application for futibatinib under priority review.”
The FDA grants drugs priority review that, if approved, would lead to significantly improved outcomes compared to the standard-of-care treatment options. By granting a treatment a priority review, the FDA agrees to speed up the review of the agent. The agency plans on deciding on whether to approve the drug by the end of September.
The filing for the expedited approval is based on findings from the phase 2b FOENIX-CCA2, which demonstrated that among 103 patients, treatment with futibatinib induced an objective response rate (the percentage of patients whose disease decreased or disappeared) of 41.7%. The results also showed that the median duration of response in patients wo received the orally delivered drug was 9.7 months. Of note, 72% of the treatment responses lasted for at least six months.
Some of the most common side effects associated with treatment included abnormal levels of phosphorous in the blood (85%), which could be a sign of kidney damage, as well as alopecia (33%) and dry mouth (30%).
Migraine was the only side effect deemed to be serious in nature that was reported in more than one patient.
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