Liver Cancer Drug Nexavar Gets Green Signal from FDA

FDA approved first liver cancer therapy drug, Nexavar (sorafenib) tablets, which will increase the chances of survival of cancer patients. Earlier in 2005, Nexavar became the first new treatment in more than a decade for advanced kidney cancer and is approved in more than 60 countries.

The drug is a supplemental New Drug Application (NDA) and will be particularly beneficial for the patients with liver cancer i.e. Unresectable hepatocellular carcinoma (HCC).

"The approval of Nexavar in HCC marks the second time in two years that this novel kinase inhibitor has been granted FDA approval on a Priority Review basis, making it rapidly available to patients who previously had limited treatment options,” said Arthur J. Higgins, Chairman of the Executive Committee, Bayer HealthCare.

“This milestone will likely establish Nexavar as the standard systemic therapy for the treatment of liver cancer and is a turning point in improving treatment outcomes in patients facing the devastating impact of this disease," he added.

Liver cancer is one of the most widely spread cancer in the world. Around 60,000 people are diagnosed of this cancer every year and lately, these figures have been on a rise. It is the third most lethal cancer and sixth most widespread type of cancer globally.

Hollings C. Renton, Chairman/President and CEO, Onyx Pharmaceuticals, Inc., thanked all the people who helped in carrying out the research and trials of this drug. Liver cancer is on the rise, as the data suggests and this makes it all the more important for us to take proper initiative to combat this lethal disease.

"This second approval for Nexavar demonstrates our commitment to expediting the clinical development of this innovative therapy to treat today's unmet needs in cancer,” he said.

The oral anticancer drug Nexavar targets the tumor cell and tumor vasculature as well. Studies show that Nexavar targets members of two classes of kinases which are known to be involved in both cell growth and blood supply (angiogenesis) - two vital processes for cancer growth.

At the same time there are some cases in which this drug might have some side effects. Hypertension may occur early in the course of therapy and blood pressure may also get affected. Most common adverse effects of Nexavar are diarrhea, nausea, fatigue, weight loss and anorexia.

Women of child-bearing potential should not do breast feeding and should also avoid becoming pregnant. In case side effects persist for longer duration, the dosage should be altered or permanently stopped.

HCC accounts for 90% of the primary malignant liver tumors in adults. 19,000 people in the USA, 54,000 in Europe, and 390,000 in China, Korea and Japan are diagnosed with liver cancer every year. Currently, the 5-year survival rate for liver cancer patients in the United States is 11 percent only. Looking at these data makes one realize the need and urgency for drug like this.

"The American Liver Foundation (ALF) is always pleased when new therapies prove effective for those affected by liver disease. Researchers worldwide, including those supported by ALF, have spent decades studying liver cancer," said James L. Boyer, M.D., chairman, board of directors, American Liver Foundation.