The Food and Drug Administration has approved Lonsurf (trifluridine and tipiracil; Taiho Oncology) for the treatment of adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

The approval was based on data from the phase 3 TAGS trial (N=507) which evaluated Lonsurf plus best supportive care (BSC) vs placebo plus BSC in patients with advanced gastric cancer; the major efficacy outcome measure was overall survival (OS). Results from the study showed a significant improvement in OS with Lonsurf compared with placebo (median OS: 5.7 months vs 3.6 months; hazard ratio [HR] 0.69, 95% CI: 0.56, 0.85; P=.0006). The most common treatment-related adverse reactions or lab abnormalities (≥10% in incidence) reported in the study were neutropenia, anemia, nausea, decreased appetite, thrombocytopenia, vomiting, and diarrhea.

Lonsurf consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase inhibitor, tipiracil. Following uptake into cancer cells, trifluridine is incorporated into DNA, interferes with DNA synthesis and inhibits cell proliferation. In addition to the metastatic gastric cancer indication, Lonsurf is also indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

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“The approval of Lonsurf represents a significant milestone for patients living with advanced gastric or GEJ adenocarcinoma who have limited effective treatment options after standard treatment options have failed,” said Timothy Whitten, President and Chief Executive Officer, Taiho Oncology, Inc.

Lonsurf is available in 2 dosage strengths: 15mg/6.14mg and 20mg/8.19mg tablets.

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