Patients with advanced colon cancer who have stopped responding to therapy have a new ally in their battle to survive. Today, the U.S. Food and Drug Administration approved Lonsurf, which is a combination of two drugs, trifluridine and tipiracil.

“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, M.D., 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.”

According to the National Cancer Institute, colorectal cancer is the second leading cause of cancer-related deaths in the United States, although deaths have decreased during the past 10 years, in part due to screenings, such as colonoscopies.

Lonsurf is a pill that is intended to treat patients with advanced (metastatic) colorectal cancer who have been previously treated with chemotherapy and biological therapy.

A randomized, double-blind study of 800 patients with previously treated advanced colorectal cancer found that patients treated with Lonsufr lived 7.1 months compared to 5.3 months for those who took a placebo.

The most common side effects of treatment with Lonsurf are anemia, a decrease in infection-fighting white blood cells (neutropenia) or blood platelets (thrombocytopenia), physical weakness, extreme tiredness and lack of energy (fatigue), nausea, decreased appetite, diarrhea, vomiting, abdominal pain and fever.