Stivarga (regorafenib), a multi-kinase inhibitor, has been approved for the treatment of metastatic colorectal cancer that has continued to spread after treatment, the FDA (Food and Drug Administration) informed today. The medication is presented as tablets and taken orally.

Stivarga is a compound which was developed by Bayer Health Care and still belongs to the company. Bayer signed an agreement with Onyx Pharmaceuticals Inc. under which Onyx is given a royalty for any future worldwide net sales of Stivarga in oncology. Stivarga will be jointly promoted in the USA by Onyx and Bayer.

Stivarga blocks a number of enzymes which are involved in encouraging cancer growth. The medication was assessed by the FDA under its priority review program that reduces the approval process to six months. Priority review programs are assigned to drugs or treatments for which no adequate therapy currently exists, or compounds that offer major treatment advances.

Stivarga’s approval has occurred one month before the product’s prescription user fee goal date (October 27th 2012). The FDA had planned to complete the review of the drug’s submission by this date.

The director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, Richard Pazdur, M.D., said:

“Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients’ lives and is the second drug approved for patients with colorectal cancer in the past two months.”

Heinz-Josef Lenz, MD, FACP, CORRECT investigator and associate director for clinical research and co-leader of the Gastrointestinal Cancers Program at the USC Norris Comprehensive Cancer Center, said:

“The approval of regorafenib adds to the treatments we have for metastatic colorectal cancer, which is important for those patients who have no further options. The drug has been shown to prolong survival and slow the progression of cancer in patients whose disease has progressed after treatment with currently available therapies. It provides patients another avenue to fight this cancer.”

Colorectal cancer is the third leading cause of cancer death in the USA, says the CDC (Centers for Disease Control and Prevention); it is also the third most common cancer among adult males and females in the country.

This year, a total of 51,690 will die from colorectal cancer, and 143,460 will be diagnosed with the disease in the USA, according to the NIH (National Institutes of Health).

The FDA examined data from a single clinical trial involving 760 patients with colorectal cancer – all of them had been previously treated. They were randomly selected into two groups:

  • The Stivarga group
  • The placebo group – these were given a dummy drug

In both cases, they were given treatment to manage side effects, as well as cancer symptoms.

According to the study results:

  • Patients in the Stivarga group survived for a median of 6.4 months
  • Participants in the placebo group lived for a median of 5 months
  • Those in the Stivarga groups had progression free survival for a median of two months (surviving with no tumor growth)
  • Patients in the placebo group experienced progression free survival of 1.7 months

The approved drug comes with a Boxed Warning, advising doctors and patients on the risk of severe and fatal liver toxicity which was reported in the Stivarga trials.

According to the clinical trial, the most common reported side effects included:

  • diarrhea
  • dysphonia (voice changes in quality and volume
  • fatigue
  • hypertension (high blood pressure
  • infection
  • mouth sores
  • palmar-plantar erythrodysesthesia (hand-foot syndrome)
  • Poor appetite
  • weakness
  • weight loss

Zaltrap (ziv-aflibercept) was approved in August 2012 to be taken together with FOLFIRI (folinic acid fluorouracil and irinotecan) chemotherapy regimen for the treatment of adults with metastatic colorectal cancer.

Colorectal cancer, also known as bower cancer, refers to any tumor of the colon or the rectum. According to WHO (World Health Organization), colorectal cancer is the second most common cancer globally, after lung cancer.

The colon and the rectum are collectively known as the large bowel. The colon reabsorbs water and nutrients from undigested food products which pass along it. The rectum, which is at the end of the colon, stores feces before it is expelled from the body.

Experts are not completely sure why some people develop colorectal cancer and others do not. There are several risk factors which have been linked to the disease.

Colorectal risk factors:

  • Age – older people have a much higher risk
  • A diet high in animal protein, saturated fats, low in dietary fiber, and high in calories
  • High and frequent alcohol consumption
  • A family history of colorectal cancer
  • Obesity/overweight
  • Smoking
  • Physical inactivity
  • Ulcerative colitis
  • Polyps present in the colon or rectum
  • Crohn’s diseased or IBS (irritable bowel syndrome)

Written by Christian Nordqvist