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news.The Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Nexavar (sorafenib) tablets for the treatment of unresectable hepatocellular carcinoma (HCC), a type of liver cancer that accounts for 95% of all liver cancer cases in the country.
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The drug is being manufactured jointly by Bayer HealthCare and Onyx Pharmaceuticals.
The approval was based on a positive data from the international, Phase III double-blind, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) study that evaluated more than 800 patients who received no prior systemic therapy, both the companies said.
The study found that Nexavar improved overall survival in patients with HCC by 44% versus placebo.
Gunnar Riemann, Member of the Executive Committee of Bayer HealthCare, said: “we are pleased with today’s approval and what it may mean for liver cancer patients in Japan and their families who now have a therapy like Nexavar that has the potential to extend their lives.”
At present, Nexavar is approved in more than 70 countries for liver cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer.
The drug is already approved in Japan for the treatment of kidney cancer.