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23 Sep 2015

Taiho Oncology announces FDA approval of Lonsurf for refractory metastatic colorectal cancer

Lonsurf represents the first FDA-approved product for Taiho Oncology, setting the stage for the company’s oncology pipeline.

Taiho Oncology has announced that FDA has approved Lonsurf (trifluridine and tipiracil), formerly known as TAS-102, for the treatment of patients with metastatic colorectal cancer (mCRC) 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.

“Patients with metastatic colorectal cancer, whose disease has progressed after treatment with standard therapies, have had limited therapeutic options to treat their disease,” said Eric Benn, Taiho Oncology’s President and CEO. “Lonsurf helps address this unmet medical need by providing patients with a new therapeutic option that can help extend their overall survival. As the first FDA approval for Taiho Oncology, Lonsurf also represents a major milestone for our company.”

“Metastatic colorectal cancer cells often become resistant to previously effective treatment, underscoring the importance of identifying new therapeutic options for patients with the disease,” said Robert J. Mayer, MD, Faculty Vice President for Academic Affairs at the Dana Farber Cancer Institute, Professor of Medicine at Harvard Medical School, and Principal Investigator of the RECOURSE study. “In a pivotal clinical trial, LONSURF demonstrated that it can extend overall survival, providing patients and their oncologists with a novel oral therapy.”

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