Nexavar® Approved for the Treatment of Kidney Cancer in Japan

First approved oral targeted therapy for metastatic RCC in Japan.

Berlin.– Bayer has been granted marketing approval of Nexavar® in Japan for the treatment of advanced renall cell carcinoma (RCC), the most common form of kidney cancer. Nexavar is an oral multi-kinase inhibitor jointly developed by Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. which targets both the tumor cell and tumor vasculature. In Japan, Nexavar is the first approved oral targeted therapy for metastatic RCC.

“This approval of Nexavar is a crucial step for patients with advanced kidney cancer in Japan”, said Dr. Gunnar Riemann, member of the Board of Management of Bayer Schering Pharma AG. “This is also a major accomplishment for the company’s oncology franchise in Japan.”

The new drug application (NDA) for Nexavar in RCC was filed in June 2006. In September 2007, an additional application for the treatment of hepatocellular carcinoma (HCC) was filed. Japanese authorities recently granted priority review status for Nexavar in this indication.

About renal cell carcinoma (RCC)
Every year, more than 200,000 people around the world are diagnosed with kidney cancer and more than 100,000 die from the disease. At the time of diagnosis, the cancer has already metastasized (spread to distant body locations) in about one-third of people with kidney cancer.

RCC is the most common kidney cancer. In Japan, there are ca. 10,000 patients suffering from kidney cancer, and 80-85% are diagnosed RCC.

Nexavar’s Differentiated Mechanism
Nexavar® targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC. Therefore, blocking signaling through Raf-1 may offer therapeutic benefits in HCC.

Nexavar is currently approved in more than 30 countries for liver cancer and in more than 60 countries for the treatment of patients with advanced kidney cancer, including the United States and the European Union. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Nexavar is also being evaluated by the companies, international study groups, government agencies, and individual investigators as a single agent or combination treatment in a wide range of other cancers, including adjuvant therapy for kidney cancers, breast cancer, non-small cell lung cancer (NSCLC), and metastatic melanoma.