FDA Approves New Oral Medication to Treat Patients With Metastatic Colorectal Cancer
Drug, formerly known as TAS-102, is approved for patients with advanced colorectal cancer who are no longer responding to other therapies
On 22 September, 2015 the US Food and Drug Administration (FDA) approved Lonsurf, a drug that combines trifluridine and tipiracil, formerly known as TAS-102, for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
Lonsurf is an oral medication intended to treat patients with mCRC who have been previously treated with chemotherapy and biological therapy.
The efficacy and safety of Lonsurf were evaluated in an international, randomised, double-blind study involving 800 patients with previously treated mCRC.
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 anaemia, neutropaenia or thrombocytopaenia, physical weakness, fatigue, nausea, decreased appetite, diarrhoea, 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 myelosuppression.
Healthcare providers are also encouraged to advise women of potential risks to developing faetuses when taking Lonsurf. Women who are taking Lonsurf should not breastfeed.
Lonsurf is manufactured by Taiho Oncology Inc. in Princeton, New Jersey.