FDA Approves Lonsurf Combination for Metastatic Colorectal Cancer

The FDA has approved Lonsurf (trifluridine/tipiracil) as a single agent or in combination with Avastin (bevacizumab) to treat adult patients with metastatic colorectal cancer (mCRC). It is indicated for patients who were previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, or an anti-EGFR therapy.

Colorectal cancer is the third most commonly diagnosed cancer in the United States. In 2023, there will be an estimated 153,020 new cases and 52,550 deaths nationwide. About 22% of U.S. patients are diagnosed after their cancer has metastasized, and these patients have a poor prognosis. The relative five-year survival rate for patients with metastatic colorectal cancer is 14%.

Developed by Taiho Oncology, Lonsurf is also approved to treat adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma. The recommended dosage for LONSURF is 35 mg/m2 orally twice daily on days 1 through 5 and days 8 through 12 of each 28-day cycle.

The most commonly ordered bottle size is 60 tablets of 20 mg, which has a wholesale acquisition cost of $15,935.23, according to a spokesperson for Taiho Oncology. Sixty tablets of 15 mg has a wholesale acquisition cost of $11,951.44. Biosimilars are available for Avastin, and the spokesperson said the Medicare Allowable for the combination of Lonsurf/bevacizumab ranges from $18,754.33 to $23,293.20 per cycle.

“Recent data has shown patients could stay on the combination for about 6 cycles (patients are treated over cycles, not calendar months),” the spokesperson said

Marwan Fakih, M.D.

The approval for colorectal cancer was based on data from the phase 3 SUNLIGHT trial, which were published in the New England Journal of Medicine in May 2023. Trial results showed that the combination of Lonsurf plus bevacizumab provided statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) for patients with mCRC.

Median overall was 10.8 months in the Lonsurf plus bevacizumab arm versus 7.5 months in the Lonsurf only arm. This improvement in OS represented a 39% reduction in the risk of death in patients with mCRC. The median progression free survival was 5.6 months in the combination arm versus 2.4 months in the Lonsurf arm. The most frequent severe treatment emergent adverse events for the combination were neutropenia and anemia.

“There is a growing need for new approaches that improve survival in this population,” Marwan Fakih, M.D., professor, medical oncology and therapeutics research, City of Hope, and lead U.S. investigator for the SUNLIGHT trial, said in a press release in May.