Bayer sees further international approval for Nexavar

Bayer has confirmed that its oral target therapy Nexavar has received marketing authorisation in Japan for the treatment of advanced renal cell carcinoma (RCC).

Developed jointly by Bayer HealthCare and Onyx Pharmaceuticals, Nexavar is an oral multi-kinase inhibitor which targets both the tumour cell and tumour vasculature.

Dr Gunnar Riemann, management board member at Bayer, described the approval as a “crucial step” for Japanese patients with advanced kidney cancer.

“This is also a major accomplishment for the company’s oncology franchise in Japan,” he added.

Nexavar is currently approved in more than 60 countries for the treatment of patients with advanced kidney cancer, including the United States and the European Union.

The new drug application for Nexavar in RCC was filed in June 2006 while in September 2007 an additional indication for the treatment of hepatocellular carcinoma (HCC) was filed.

In Europe, Nexavar is approved for the treatment of HCC and the Japanese authorities have recently granted priority review in this application.

RCC is the most common form of kidney cancer with more than 10,000 patients suffering from the kidney cancer in Japan.

Earlier this month, Bayer welcomed a new head of communications with the appointment of Michael Schade who will take responsibility of the firm’s global communication activities.