August 2021: Infigratinib (Truseltiq, QED Therapeutics, Inc.), a kinase inhibitor, has been granted accelerated approval by the Food and Drug Administration for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
The FDA also approved FoundationOne® CDx (Foundation Medicine, Inc.) as a companion diagnostic device for infigratinib treatment in patients with FGFR2 fusion or additional rearrangements.
CBGJ398X2204 (NCT02150967), a multicenter open-label single-arm trial with 108 patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement as verified by local or central tests, demonstrated efficacy. Infigratinib 125 mg orally once daily for 21 days, followed by 7 days off therapy, was given to patients in 28-day cycles until disease progression or unacceptable toxicity.
Overall response rate (ORR) and duration of response (DoR) were the primary efficacy outcome measures, as established by a blinded independent central review in accordance with RECIST 1.1. With 1 complete response and 24 partial responses, the ORR was 23% (95 percent CI: 16, 32). The average DoR was 5 months (95 percent CI: 3.7, 9.3). Eight of the 23 responders kept their answer for six months or longer.
Hyperphosphatemia, increased creatinine, nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhoea, dry skin, decreased appetite, vision blurred, and vomiting were the most common adverse reactions (incidence 20%). Hyperphosphatemia and retinal pigment epithelial detachment are major hazards, and patients should be monitored for these side effects during treatment.
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In 28-day cycles, the recommended infigratinib dose is 125 mg orally once day on an empty stomach for 21 days, followed by 7 days off medication.
Reference: https://www.fda.gov/
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