After years of trying, the drug Lonsurf is finally deemed useable to treat patients with advanced colorectal cancer.
On Sept. 22, the Food and Drug Administration (FDA) announced the approval of using Lonsurf, a combination of drugs manufactured by the Taiho Oncology Inc., to treat colorectal cancer tumors that no longer respond to other forms of therapy.
"Patients with metastatic colorectal cancer, whose disease has progressed after treatment with standard therapies, have had limited therapeutic options to treat their disease," said Eric Benn, Taiho Oncology's CEO and President.
Trifluridine, one of Lonsurf's active ingredients, was once rejected as being too toxic to be used as a chemotherapeutic drug. However, the new clinical trials showed new, promising feedback on its use.
"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. of the FDA's Center for Drug Evaluation and Research. "But there are many patients who still need additional options."
He said that the approval of Lonsurf shows the FDA's continued commitment to find new drugs and treatments with other companies to satisfy unmet health needs.
In latest clinical trials, patients who have used Lonsurf demonstrated increased overall survivability by up to two months for patients who are no longer responsive to other treatments. But while the combination of trifluridine and tipiracil helped combat the excessive toxicity of the former, a considerable list of adverse effects still remain. Side effects include extreme fatigue, loss of appetite, anemia, immune system suppression, abdominal pain and vomiting.
The FDA advised prescribers to run complete blood count tests on patients prior to each cycle of treatment and to monitor red and white blood cell levels, which are especially prone to drop during therapy.
According to the National Institute of Health, colorectal cancer is the third most common type of cancer in adults. Colorectal cancer occurs when cancerous or abnormal cells begin to grow in the large intestines. They may start as benign polyps at first but can progress to malignant tumors.
Treating colorectal cancer during its early stages often gets the most favorable results, but treatment options for patients either in the advanced phases of the disease or those who have grown resistance to existing chemotherapy tend to have lower survival rates.
Benn said Lonsurf is meant to help give these patients other treatment options and lengthen their lifespans.
"As the first FDA approval for Taiho Oncology, Lonsurf also represents a major milestone for our company," the CEO added.
Photo: Phil and Pam Gradwell | Flickr
