Colorectal Cancer Combo Rx Gets Green Light

Lonsurf (trifluridine, tipiracil) FDA-approved to treat advanced colorectal cancer

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) When other treatments don't work for colorectal cancer patients, a new medication might.

That's the reasoning behind the US Food and Drug Administration's (FDA) decision today to approve Lonsurf (trifluridine and tipiracil) to treat advanced colorectal cancer patients who haven't responded to other treatments.

“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, in a press release. “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.”

Lonsurf, a product of Taiho Oncology in Princeton, NJ, is approved only to treat advanced colorectal cancer patients who haven't had luck with other therapies, such as existing chemotherapy regimens.

Advanced colorectal cancer is metastatic, meaning that it has spread to other parts of the body from the colon or rectum. Not counting skin cancers, colorectal cancer is the third most common cancer in US patients, according to the FDA.

Lonsurf, an oral medication, received the FDA's nod of approval after it appeared safe and effective in a trial of more than 800 previously treated advanced colorectal cancer patients. Compared to patients who received a placebo (fake pill), those who received Lonsurf survived an average of 2.2 months longer. Lonsurf also appeared to slow the cancer's progression, the FDA reports.

Some common side effects of Lonsurf include a compromised immune system, anemia, weakness, fever and vomiting, among others. The FDA noted that doctors should closely monitor patients taking Lonsurf, as it can lead to severe bleeding problems.

The FDA also warned that pregnant women and mothers who are breastfeeding their children should not take Lonsurf.

Reviewed by: 
Review Date: 
September 22, 2015
Last Updated:
September 22, 2015