Colorectal cancer pill Lonsurf gets approved by FDA

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The US Food and Drug Administration has green-lighted the drug Lonsurf intended for advanced colorectal cancer patients.

According to the US agency, Lonsurf is a combination of trifluridine and tipiracil, intended for patients with advanced colorectal cancers who are no longer responding to other anti-cancer treatments.

"The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease," Dr. Richard Pazdur of the FDA's Center for Drug Evaluation and Research said in a press release. "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."

According to HealthDay, Lonsurf is made by Taiho Oncology. The medicine comes in an oral form and has been tested for safety and efficacy in a study with 800 patients diagnosed and treated for advanced colorectal cancer. They were given either Lonsurf or a placebo. Those who took Lonsurf lived more than 7 months, while those on the fake pill only lasted about 5 months.

"In a pivotal clinical trial, LONSURF demonstrated that it can extend overall survival, providing patients and their oncologists with a novel oral therapy." said Dr. Robert Mayer, lead investigator of the study from the Harvard Medical School, via PR Newswire.

Lonsurf has long been available in Japan, having been approved in March 2014, to treat advanced or recurrent colorectal cancer.

"Data from the pivotal RECOURSE study demonstrated a significant survival benefit for patients with refractory metastatic colorectal cancer, whose disease had progressed after standard therapies, reducing the risk of death in these patients by 32 percent," said Dr. Fabio Benedetti, Taiho Oncology's Chief Medical Officer. "This significant milestone underscores our longstanding commitment to patients challenged by metastatic colorectal cancer and to bringing new treatment options to them."

Those who take Lonsurf may experience common side effects including diarrhea, vomiting, fever, fatigue, nausea, abdominal pain, and anemia, reports Newsmax.

Colorectal cancer starts in the patient's colon or rectum and can begin as a small growth or polyps. According to WebMD, the exact cause of this type of cancer is not yet known however, several factors that can increase the risk of colorectal cancer including heredity, smoking and drinking, exposure to  certain chemicals such as chlorine, fat-rich diet and other diseases including Crohn's disease or ulcerative colitis.

According to the Centers for Disease Control and Prevention, colorectal cancer is the second leading cause of cancer deaths in the US and is the third most common cancer for men and women.