Japan grants priority review status to Bayer's Nexavar

The Japanese health authority (MHLW) has granted Bayer priority review status (fast-track procedure) for marketing authorization of its anticancer drug product Nexavar (sorafenib) for the treatment of hepatocellular carcinoma (HCC). In addition, the contrast agent Primovist (gadoxetic acid disodium) for magnetic resonance imaging of the liver was recently granted regulatory approval in Japan. This product is scheduled to be launched on the Japanese market in the immediate future.

Nexavar, an oral anti-cancer drug, is the first and only drug shown to significantly improve overall survival in patients with HCC. In Japan, Nexavar was filed in June 2006 for the treatment of renal cell carcinoma (RCC) and an additional application for HCC was submitted in September 2007.

Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year and incidence is increasing. Japan has the second largest population of liver cancer patients in the world; most of them suffer from HCC which claims 36,000 lives every year. Thus, the medical need for an early and reliable diagnosis and for life-prolonging treatment is high.

"The fact that the Japanese authorities granted priority review status underlines the high medical need for innovative treatments options for patients with liver cancer. This devastating disease is one of the cancers in which the number of related deaths continues to increase," said Paolo Pucci, president, Global Business Unit Oncology, Bayer HealthCare. "We at Bayer are highly committed to expediting the clinical development of this innovative therapy also across additional tumour types."

Primovist is authorized for the detection and characterization of liver lesions by magnetic resonance imaging (MRI) including liver tumours such as hepatocellular carcinomas (HCC), liver metastases and other malignant and benign lesions.

"Primovist is a gadolinium-based contrast medium that offers the possibility to simultaneously detect, locate and distinguish various types of liver lesions, thus providing a powerful tool that increases the diagnostic confidence", said Professor Hans Maier, Head, Global Business Unit Diagnostic Imaging, Bayer Schering Pharma. "Primovist enables radiologists to identify even tiny pathological liver lesions; it thus helps to guide and follow-up on treatment decisions and has the potential to considerably optimize patient benefit."