Posted by Michael Wonder on 19 Apr 2023
US FDA accepts for priority review Taiho Oncology's supplemental new drug application for the use of trifluridine/tipiracil (Lonsurf) in combination with bevacizumab for refractory metastatic colorectal cancer
18 April 2023 - The supplemental new drug application is supported by data from the Phase 3 SUNLIGHT clinical trial, the first to show improved efficacy over an approved comparator in adults with refractory metastatic colorectal cancer.
Taiho Pharmaceutical announced today that the US FDA has accepted for priority review the supplemental new drug application for trifluridine/tipiracil (Lonsurf) as monotherapy or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
