FDA Approves Trifluridine for Colorectal Cancer Treatment

Patients treated with the drug showed improvements in overall survival.

The FDA today approved trifluridine/tipiracil for the treatment of patients with colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

The approval followed clinical research that showed improvement in overall survival in a multicenter, double-blind, placebo-controlled trial. A cohort of 800 patients were observed, all of whom had previous treatment for metastatic colorectal cancer, and randomly allocated to receive trifluridine/tipiracil plus best supportive care or matching placebo plus best supportive care.

Patients were included in the trial if there was absence of brain metastasis, absence of ascites requiring drainage in the past four weeks, and if they had ECOG 0-1. Patients received 35 mg/m² trifluridine/tipiracil or matching placebo orally twice daily on days 1 through 5 and 8 through 12 of each 28-day cycle until disease progression or unacceptable toxicity occurred.

A significant improvement to overall survival was observed in patients having a median overall survival rate of 7.1 and 5.3 months in the trifluridine/tipiracil and placebo arms, respectively.

Common side effects observed within the trial included anemia, neutropenia, asthenia/fatigue, nausea, thrombocytopenia, decreased appetite, diarrhea, vomiting, abdominal pain, and pyrexia. The most common side effects that led to dose reduction were anemia, neutropenia, febrile neutropenia, fatigue, and diarrhea.

Trifluridine/tipiracil should be taken at a dose of 35 mg/m² twice daily within an hour of eating breakfast and dinner on days 1 through 5 and 8 through 12 during the 28-day cycle until disease progression or unacceptable toxicity is reached.

Health care professionals are advised to report any adverse effects experienced by their patients as a direct result of taking the medication to the FDA’s MedWatch Reporting System by completing the online form or calling by phone.