Taiho Oncology Announces FDA Approval of Lonsurf

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Treatment indicated for adult patients with metastatic colorectal cancer.

Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. have revealed that the FDA officially approved Lonsurf (trifluridine/tipiracil) as either a single agent or combo with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC). According to the company, the approval was based on positive results from its phase three sunlight trial.


"The treatment of advanced colorectal cancer has been a core focus of our work at Taiho Oncology since our inception and with good reason: approximately 22% of patients with colorectal cancer in the U.S. are diagnosed after the cancer has metastasized," said Timothy Whitten, president, CEO, Taiho Oncology, Inc. "The FDA approval of LONSURF in combination with bevacizumab is another example of how we are continuing to advance care in this disease and provide new hope to patients and their families."

Reference: FDA Approves LONSURF® (trifluridine/tipiracil) in Combination With Bevacizumab for Adult Patients With Metastatic Colorectal Cancer (mCRC). PR Newswire. August 2, 2023. Accessed August 3, 2023. https://www.prnewswire.com/news-releases/fda-approves-lonsurf-trifluridinetipiracil-in-combination-with-bevacizumab-for-adult-patients-with-metastatic-colorectal-cancer-mcrc-301892077.html