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FDA News Release

FDA approves new oral medication to treat patients with advanced colorectal cancer

For Immediate Release

September 22, 2015

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The U.S. Food and Drug Administration today approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies.

“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.”

Colorectal cancer is the third most common non-skin cancer in men and women in the U.S., according to the National Cancer Institute. While still the second leading cause of cancer-related death in the U.S., over the past 10 years the number of colorectal cancer cases and related deaths have decreased, due in part to screenings, such as colonoscopies. 

Lonsurf is an oral medication intended to treat patients with advanced (metastatic) colorectal cancer who have been previously treated with chemotherapy and biological therapy.

The efficacy and safety of Lonsurf were evaluated in an international, randomized, double-blind study involving 800 patients with previously treated metastatic colorectal cancer.  

Study participants received Lonsurf plus best supportive care, or placebo plus best supportive care until their disease worsened or side effects became intolerable. The primary endpoint of the study was overall survival and the secondary endpoint was progression-free survival. Patients treated with Lonsurf lived an average of 7.1 months compared to 5.3 months for those treated with placebo. On average, the time to disease progression was two months for patients on Lonsurf compared to 1.7 months for patients receiving 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.

The FDA recommends that health care providers obtain complete blood counts prior to starting each treatment cycle of Lonsurf and monitor patients throughout treatment, as Lonsurf may cause a severe decrease in blood cell and platelet production (myelosuppression).

Healthcare providers are also encouraged to advise women of potential risks to developing fetuses when taking Lonsurf. Women who are taking Lonsurf should not breastfeed.

Lonsurf is manufactured by Taiho Oncology Inc. in Princeton, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Page Last Updated: 09/22/2015
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