The American FDA has approved of the use of Nexavar (sorafenib), manufactured by Bayer HealthCare AG and Onyx Pharmaceuticals Inc, as a liver cancer drug. This puts it way ahead of any competitors.
Nexavar had already been approved of in 2005dfor the treatment o f kidney cancer in over 60 countries, including the USA. Now it will be the first to be also used for liver cancer or HCC that cannot be surgically removed.
Liver cancer or HCC can be difficult to remove completely with surgery. Then, when all of the cancer is not removed, the disease proves fatal in about three to six months.
Every year, about 600,000 people die from the sixth most common form of cancer in the world, liver cancer. Over 50%of these fatalities occur in China where additional trials are being carried out of the drug. It is also is being further tested in Japan.
European regulators approved of the use of Nexavar against liver cancer in October, 2007.
Chairman of the Executive Committee, Bayer HealthCare, Arthur J. Higgins, said that the approval marked the second time in two years that “this kinase inhibitor has been granted FDA approval on a Priority Review basis, making it rapidly available to patients who previously had limited treatment options.”
He claimed that this milestone would in all likelihood “establish Nexavar as the standard systemic therapy for the treatment of liver cancer.” This, he said was “a turning point in improving treatment outcomes in patients facing the devastating impact of this disease."
Chairman/President and CEO, Onyx Pharmaceuticals, Inc., Hollings C. Renton, said this second approval for Nexavar demonstrated their “commitment to expediting this clinical development of the innovative therapy to treat today's unmet needs in cancer.”
Onyx Pharmaceuticals, based in Emeryville, California, made a report of its first quarterly profit because of off-label sales of Nexavar last month. This was a result of an Onyx' June report which claimed that in their clinical trials involving 602 patients, the efficacy of the drug in extending the life of patients had been proven. Forty four percent of the patients who had received Nexavar survived a median of 10.7 months whereas patients who were administered only a placebo survived for a median of 7.9 months.
About twenty percent of the patients on Nexavar experienced at least one side effect such as weight loss, hair loss, fatigue, nausea and abdominal pain, hand/foot skin reactions and Diarrhea. There were also increased cases of heart attack or insufficient blood supply to the heart as well as new cases high blood pressure in some of those who had taken the treatment.
But another analysis revealed that tumors progressed more slowly in the case of patients who received Nexavar compared to patients who had received only a placebo.
Nexavar is believed to target both, the tumor cell, and the tumor vasculature. Preclinical studies proved that it targets two classes of kinases known to be involved in both cell growth and blood supply (angiogenesis) – which are two vital processes for the growth of cancer.
Although the cost is extremely high, working out to $4,700 each month, the treatment consists of taking just two tablets twice a day.
