FDA approves Taiho Oncology’s Lonsurf

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced the approval of Taiho Oncology’s Lonsurf (trifluridine and tipiracil). The pill, a combination of two drugs, is intended to treat metastatic colorectal cancer that has stopped responding to other therapies. 

“The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “But there are many patients who still need additional options, and today’s approval is a testament to the FDA’s commitment to work with companies to develop new drugs in disease areas where unmet needs remain.” 

Lonsurf marks the first FDA approval for Taiho Oncology.

“Patients with metastatic colorectal cancer, whose disease has progressed after treatment with standard therapies, have had limited therapeutic options to treat their disease,” Taiho president and CEO Eric Benn said. “Lonsurf helps address this unmet medical need by providing patients with a new therapeutic option that can help extend their overall survival.”