The US Food and Drug Administration (FDA) announced their approval of Lonsurf – a combination of two drugs – to treat advanced stage colorectal cancer. The treatment consists of two active ingredients – trifluridine and tipiracil – and will be administered to patients who no longer respond to frontline therapies.
Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research, said, “The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease. 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.”
Not including skin cancer, colorectal cancer is the third most common type of cancer afflicting men and women in the US, according to the National Cancer Institute. Though in the last 10 years, the overall number of cases of colorectal cancer – and the number of deaths from the disease – have decreased, it still remains the number two leading cause of cancer-related deaths in the US. Doctors attribute the reduction in colorectal cancer-related deaths – in part – to colonoscopies and other screening initiatives.
Lonsurf was developed to treat patients with advanced colorectal cancer – characterized by tumor metastasis – who have already received biological therapy and chemotherapy. The drug – which is taken orally – was evaluated using a randomized, double-blind clinical trial, which was conducted internally.
The study participants – 800 patients with metastatic colorectal cancer who had received previous treatment – were randomly assigned into one of two trial groups: patients who received Lonsurf in conjunction with best supportive care, or patients who received a placebo in addition to best supportive care. The participants remained in the study until side effects became unbearable, or until the disease progressed.
The primary endpoint of the study was measured as survival of the colorectal cancer patients, with the secondary endpoint being defined as survival without progression of the cancer. The results of the study indicated that patients who were administered Lonsurf, lived an average of 7.1 months, while those participants who received the placebo lived an average of 5.3 months.
Treating patients with Lonsurf resulted in prolonging the time before progression of the disease by 0.3 months; in patients receiving the drug, the cancer progressed in 2 months, on average, while in patients receiving the placebo, their cancer progressed in 1.7 months, on average.
Lonsurf – produced by Taiho Oncology Inc. – does have a number of associated side effects including, anemia, a decrease in white blood cell count (neutropenia) or platelets (thrombocytopenia), weakness, fatigue, nausea, decreased appetite, diarrhea, vomiting, fever and abdominal pain. Lonsurf may also cause myelosuppression – a severe decrease in blood cell count. The FDA recommends that doctors do a baseline blood cell count prior to treatment, in order to facilitate patient monitoring.
- FDA approves new oral medication to treat patients with advanced colorectal cancer – http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463650.htm