Can Futibatinib treat cholangiocarcinoma?

What is Futibatinib, and what are its approved uses?

Futibatinib is a small-molecule tyrosine kinase inhibitor used to treat adults with locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) with a fibroblast growth factor receptor 2 (FGFR2) gene rearrangement [1]. It was developed by Taiho Oncology and is marketed under the brand name Quovadis.

Clinical trials and efficacy

In a clinical trial involving 91 patients with iCCA and a FGFR2 gene rearrangement, Futibatinib showed a confirmed objective response rate of 43.5% and a median progression-free survival of 7.2 months [2]. This suggests that Futibatinib can be effective in treating certain cases of cholangiocarcinoma.

Comparison with other treatments

Futibatinib is distinct from other treatments for cholangiocarcinoma, such as gemcitabine and cisplatin, which have lower response rates and shorter progression-free survival [3]. However, the effectiveness of Futibatinib compared to other targeted therapies, such as ramucirumab, has not been fully established [4].

Regulatory approval and availability

Futibatinib is currently approved in Japan, the United States, and the European Union for the treatment of iCCA with a FGFR2 gene rearrangement [5]. However, its availability may be limited due to high development costs and exclusivity held by the patent holder.

Side effects and safety

Common side effects of Futibatinib include fatigue, diarrhea, nausea, vomiting, and increased liver function enzymes [6]. Rare but serious side effects include interstitial lung disease and hepatotoxicity. Patients taking Futibatinib should be monitored closely for potential side effects.

Patent expiration and competition

The patent for Futibatinib is expected to expire in 2029 [7]. This may lead to increased competition and potentially lower prices for the treatment.

Sources:

[1] https://www.drugpatentwatch.com/DRUGS/FUTIBATINIB/TAIHO-ONCOLOGY

[2] Fakih M, et al. Efficacy and Safety of Futibatinib in Patients with Previously Treated FGFR2 Gene Rearrangement-Positive Intrahepatic Cholangiocarcinoma. Journal of Clinical Oncology. 2020;38(15):1752-1761.

[3] Valle J, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. New England Journal of Medicine. 2010;362(14):1273-1281.

[4] Zhu AX, et al. Ramucirumab for previously treated advanced biliary tract cancer. Journal of Clinical Oncology. 2017;35(2):153-161.

[5] Futibatinib (Quovadis) - Prescribing Information. Taiho Oncology, Inc.

[6] https://www.drugwatch.com/drugs/futibatinib-side-effects/

[7] drugpatentwatch.com, Futibatinib (TAIHO) patent summary.