Bayer and partner Onyx Pharmaceuticals are celebrating again following the news that the firm’s Nexavar has received the blessing of US regulators as a treatment for liver cancer.

The US Food and Drug Administration has approved a supplemental New Drug Application for Nexavar (sorafenib) for the treatment of patients with unresectable hepatocellular carcinoma. The only therapy shown to significantly improve overall survival in patients with liver cancer, it was approved in Europe for the treatment of HCC last month. Nexavar first hit the market in 2005 when it became the first new drug in more than a decade for advanced kidney cancer and it is currently approved in more than 60 countries for that indication.

The FDA approval is based on positive data from the Phase III SHARP trial. That study demonstrated that the drug extended overall survival by 44% in patients with HCC versus placebo and the study revealed no significant differences in serious adverse event rates between Nexavar and placebo-treated groups. Arthur Higgins, head of Bayer HealthCare, noted that the green light in the USA “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”. He added that this will “likely establish Nexavar as the standard systemic therapy for the treatment of liver cancer and is a turning point in improving treatment outcomes.”

Liver cancer is the third leading cause of cancer-related deaths globally. More than 600,000 cases are diagnosed worldwide each year (19,000 in the USA, 54,000 in Europe and 390,000 in China, Korea and Japan) and the incidence is increasing, Bayer noted.

Bayer spending 1 billion euros to cut greenhouse gases
Bayer has also announced that it will spend 1 billion euros over three years with the goal of cutting CO2 emissions from its production facilities, using its “specific expertise as an inventor company”.
The Leverkusen-headquartered firm has already cut such emissions, by 36% between 1990 and 2006, and it plans to reduce them further up to 2020.

By that time, the MaterialScience division has a target of lowering emissions by 25%, while the healthcare unit’s target is 5%.