FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer


On August 2, 2023, the Food and Drug Administration approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. FDA had previously approved single-agent LONSURF for this indication in September 2015.

View full prescribing information for LONSURF.

Safety and efficacy were evaluated in SUNLIGHT (NCT04737187), a randomized, open-label, multicenter, global trial of LONSURF with bevacizumab compared to single-agent LONSURF in 492 patients with mCRC who received a maximum of two prior chemotherapy regimens and demonstrated progressive disease or intolerance to the last regimen.

The primary efficacy outcome measures were overall survival (OS) and progression-free survival (PFS). The trial demonstrated a statistically significant OS improvement in patients randomized to the LONSURF plus bevacizumab arm compared to those randomized to LONSURF (Hazard ratio 0.61; 95% CI: 0.49, 0.77; 1-sided p<0.001). Median OS was 10.8 months in the LONSURF plus bevacizumab arm (95% CI: 9.4, 11.8) and 7.5 months in the LONSURF arm (95% CI: 6.3, 8.6). Median PFS was 5.6 months in the LONSURF plus bevacizumab arm (95% CI: 4.5, 5.9) and 2.4 months in the LONSURF arm (95% CI: 2.1, 3.2) (Hazard ratio 0.44; 95% CI: 0.36, 0.54; 1-sided p<0.001).

The most common adverse reactions or laboratory abnormalities for LONSURF with bevacizumab (≥20%) are neutropenia, anemia, thrombocytopenia, fatigue, nausea, increased AST, increased ALT, increased alkaline phosphatase, decreased sodium, diarrhea, abdominal pain, and decreased appetite.

The recommended LONSURF dose is 35 mg/m2 orally twice daily with food on days 1 through 5 and days 8 through 12 of each 28-day cycle. Refer to the Prescribing Information for bevacizumab dosing information.

This application was granted priority review designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

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