News

Lonsurf® Approved for the Treatment of Colorectal Cancer

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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. Fortunately, however, death rates have declined in the past 10 years which is thought to be due to increased screening and newer drugs to treat the disease.

Trifluridine and tipiracil 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 agents, trifluridine and tipiracil.

The international clinical trial that prompted the approval of trifluridine and tipiracil included 800 patients with advanced colorectal cancer that had stopped responding to prior therapies. One group of patients was treated with trifluridine and tipiracil plus best supportive care, and the other group of patients received placebo (inactive “sugar pill”) plus best supportive care.

Patients treated with trifluridine and tipiracil 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 trifluridine and tipiracil compared to 1.7 months for those who received placebo).

The most common side effects with trifluridine and tipiracil 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: www.fda.gov.