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FDA Approval of Trifluridine and Tipiracil With Bevacizumab for Patients With Previously Treated Metastatic Colorectal Cancer
On August 2, 2023, the United States Food and Drug Administration (FDA) granted approval to trifluridine and tipiracil plus bevacizumab for the treatment of patients with metastatic colorectal cancer who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
This regulatory decision is based on the results of the global, open-label, phase 3 SUNLIGHT trial, in which patients with metastatic colorectal cancer who had received a maximum of 2 chemotherapy regimens and demonstrated progression or intolerance to the last regimen were randomized to receive either trifluridine-tipiracil alone or trifluridine-tipiracil plus bevacizumab. The primary efficacy outcomes were overall survival (OS) and progression-free survival (PFS).
There was a statistically significant improvement of the OS among those patients in the combination arm (10.8 months) vs the monotherapy arm (7.5 months; hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.49 to 0.77; 1-sided P < .001). The median PFS in the combination arm was 5.6 months compared with 2.4 months in the monotherapy arm (HR, 0.44; 95% CI, 0.36 to 0.54; 1-sided P < .001).
The most common adverse reactions/lab abnormalities, occurring in ≥20% of patients in the combination arm, were neutropenia, anemia, thrombocytopenia, fatigue, nausea, increase AST, increase ALT, increased alkaline phosphatase, decreased sodium, diarrhea, abdominal pain, and decreased appetite.
The recommended dose is 35 mg/m2 trifluridine-tipiracil twice daily with food on days 1 through 5, and 8 through 12 of each 28-day cycle. Clinicians are advised to refer to the Prescribing Information for the recommended dose of bevacizumab.
Source:
FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer. US Food and Drug Administration. Published August 2, 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-trifluridine-and-tipiracil-bevacizumab-previously-treated-metastatic-colorectal-cancer
