Nexavar Approved for Liver Cancer Treatment
The US FDA has recently approved the oral kinase inhibitor Nexavar (sorafenib) for use in patients with hepatocellular carcinoma, an inoperable form of liver cancer. This makes Nexavar the “first FDA-approved drug therapy for liver cancer.” Nexavar was originally approved in 2005 for treatment of advanced kidney cancer and is currently marketed in over 60 countries for this indication [1, 2].
The FDA approval came about month after Nexavar was centrally approved in Europe in October for the new indication. The appproval was based on results of a randomized placebo-controlled trial involving 602 patients with hepatocellular carcinoma. The study results showed an average extended survival of 2.8 months in patients treated with Nevaxar compared to placebo. Tumor progression was also observed to be slower.
“Nexavar, an oral anti-cancer drug, is the first approved systemic drug therapy for liver cancer and the only drug therapy shown to significantly improve overall survival in patients with the disease.” [1,2]
Nexavar is manufactured by Bayer Pharmaceuticals Corporation of Germany.
[2] Bayer Press Release, 19 Nov 2007
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