Taiho Oncology announced that the Food and Drug Administration (FDA) has approved Lonsurf (trifluridine and tipiracil) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyramidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
The FDA approval was based on data from the global Phase 3 RECOURSE trial (n=800) in patients who were previously treated for mCRC. The study met the primary efficacy endpoint of statistically significant improvement in overall survival (OS) compared to placebo (HR 0.68, CI: 0.58, 0.81; P<0.001). Treatment with Lonsurf reduced the risk of death by 32% vs. placebo. Median OS was 7.1 months for Lonsurf and 5.3 months for placebo, respectively.
Lonsurf combines trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor. Inclusion of tipiracil increases trifluridine exposure by inhibiting its metabolism by thymidine phosphorylase. Following uptake into cancer cells, trifluridine is incorporated into DNA, interferes with DNA synthesis and inhibits cell proliferation.
Lonsurf will be available as 15mg/6.14mg and 20mg/8.19mg strength tablets in 20-, 40-, and 60-count bottles.
For more information call (844) 878-2446 or visit TaihoOncology.com.