Lonsurf Granted Approval for Advanced Colorectal Cancer

A combination pill to treat metastatic colorectal cancer (mCRC) patients who are refractory to other treatments has received the FDA’s endorsement. Developed by Princeton-based Taiho Oncology Inc, Lonsurf (TAS-102) is an oral 2-drug combination pill that includes trifluridine and tipiracil and is intended for mCRC patients who have failed on chemotherapy and biological therapy.

Excluding melanoma, CRC is the third most common cancer diagnosed in the United States and the third leading cause of cancer-related deaths in the United States. According to the National Cancer Institute, CRC will be responsible for about 8.4% of cancer-related deaths in 2015.

Today's approval was based on Taiho’s submission of results from its phase 3 RECOURSE trial, an international, randomized, double-blind, study that included nearly 800 participants from the United States, Japan, and the European Union. The results, presented this year at the annual meeting of the American Society of Clinical Oncology, found that overall survival (OS) improved in mCRC patients in the TAS-102 arm across all 3 geographical subgroups—patients treated with TAS-102 lived an average of about 2 months longer compared with those given the placebo. Overall, the incidence of adverse events (AEs), serious AEs, and hospitalizations was similar across the subpopulations treated with TAS-102.

Because of the drug’s myelosuppressive effect, the FDA has advised physicians to obtain a complete blood count on patients prior to each treatment cycle and to continue monitoring them during treatment.

“The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease,” said Richard Pazdur, MD, 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.”