FDA OKs New Oral Drug for Refractory Colorectal Cancer

Patients with advanced colorectal cancer who are no longer responding to other therapies will now have another option, a new oral medication.

The new product, a combination of trifluridine and tipiracil (Lonsurf, Taiho Pharmaceutical Co, Ltd) has just been approved by the US Food and Drug Administration (FDA).

Previously known by the code nameTAS-102, the product is a combination of two active ingredients ― trifluridine, a nucleoside analogue, and tipiracil hydrochloride, a thymidine phosphorylase inhibitor, which prevents the rapid metabolism of trifluiridine, thereby increasing its bioavailability.

"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. "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," Dr Pazdur said in a statement.

The new product is indicated for use in patients with advanced/metastatic colorectal cancer who have been previously treated with chemotherapy and biological therapy.

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

Study participants received best supportive care and were assigned to the new product or placebo; participants received their regimens until their disease worsened or side effects became intolerable. The primary end point of the study was median overall survival, which was 7.1 months with Lonsurf vs 5.3 months with placebo. The secondary end point was progression-free survival, which was 2 months with Lonsurf vs 1.7 months with placebo.

The most common side effects of treatment with Lonsurf are anemia, neutropenia or thrombocytopenia, physical weakness, fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever, the FDA noted.

The agency also recommends that healthcare providers obtain complete blood counts prior to starting each treatment cycle of Lonsurf and monitor patients throughout treatment, because the product may cause severe myelosuppression.

Healthcare providers are also encouraged to advise women of potential risks of fetotoxicity and warn women not to breastfeed while taking the drug.


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FDA OKs New Oral Drug for Refractory Colorectal Cancer. Medscape. Sep 22, 2015.

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