Drug for advanced RCC receives FDA approval

January 5, 2006

The FDA has approved sorafenib (Nexavar) for the treatment of advanced renal cell carcinoma.

The FDA has approved sorafenib (Nexavar) for the treatment of advanced renal cell carcinoma. Sorafenib, the first FDA-approved treatment for advanced RCC in more than a decade, has been shown to double progression-free survival in patients with the disease, according to Bayer Healthcare AG, which co-developed the drug with Onyx Pharmaceuticals, Inc.

The FDA approved sorafenib based on data from the largest ever randomized, placebo-controlled, international trial in patients with advanced RCC, in which 130 centers participated, Bayer said. Treatment resulted in approximately a doubling of progression-free survival.

Sorafenib is an oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumor cell and tumor vasculature. In preclinical models, the drug targeted members of two classes of kinases known to be involved in both tumor cell proliferation and tumor angiogenesis.

In the larger of two pivotal studies of sorafenib in patients with advanced RCC, most patients had previously received treatment with interleukin-2 or interferon. The median time to tumor progression or death in the sorafenib-treated arm was 167 days compared with 84 days in those patients not treated with the drug.

Common temporary side effects reported with sorafenib are rash, diarrhea, increases in blood pressure, and redness, pain, swelling, or blisters on the hands or feet.