The United States Food and Drug Administration (FDA) has approved the oral agent, Lonsurf® (trifluridine and tipiracil), for the treatment of colorectal cancer.
Colorectal cancer remains the second leading cause of cancer-related deaths in the U.S. although death rates from colorectal cancer have declined in the past 10 years which is thought to be due to increased screening and newer drugs to treat the disease.
Lonsurf is approved, specifically, for the treatment of advanced colorectal cancer that has stopped responding to standard therapies including chemotherapy and biologic therapy. It is a comprised of the two active anti-cancer agents, trifluridine and tipiracil.
The international clinical trial that prompted the approval of Lonsurf included 800 patients with advanced colorectal cancer that had stopped responding to prior therapies. One group of patients was treated with Lonsurf plus best supportive care, and the other group received a placebo (inactive “sugar pill”) plus best supportive care.
Patients treated with Lonsurf lived an average of 7.1 months, compared with only 5.3 months for those who received placebo.
Time to cancer progression was comparable between the two groups of patients (2 months for those treated with Lonsurf compared to 1.7 months for those who received placebo).
The most common side effects with Lonsurf were low levels of blood cells and fatigue/weakness.
Reference: United States Food and Drug Administration FDA news release: FDA approves new oral medication to treat patients with advanced colorectal cancer. Accessed September 22, 2015. Available at:
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