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news.Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have applied for the European Medicines Agency's approval to market Nexavar for the treatment of hepatocellular carcinoma, a cancer of the liver.
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Nexavar is currently approved in more than 50 countries for the treatment of advanced kidney cancer. The companies plan to file a supplemental new drug application with the FDA for Nexavar in the treatment of liver cancer this summer.
The MAA submission is based on positive data from a phase III trial which demonstrated that Nexavar extended overall survival by 44% in patients with hepatocellular carcinoma (HCC) versus placebo.
There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups, with the most commonly observed serious adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction.
According to the companies, there are currently no EMEA-approved drug therapies that significantly extend survival of liver cancer patients.
HCC, the most common form of liver cancer, is responsible for about 90% of the primary malignant liver tumors in adults, and is the fifth most common cancer in the world.