Bayer, Onyx to File NDA for Sorafenib

Onyx Pharmaceuticals and Bayer Pharmaceuticals plan to file a new drug application (NDA) for cancer drug candidate BAY 43-9006, based on the results of a Phase III study that showed the drug delayed the progress of the disease in patients with advanced kidney cancer, Onyx said.

"The progress represents a clinical milestone in the development of targeted cancer therapy for patients with kidney cancer," Onyx Chairman, President and CEO Hollings Renton said during a conference call. "This is the first randomized study demonstrating that an oral targeted agent significantly delays disease progression in patients with advanced renal cancer."

Assuming the NDA process goes smoothly, the companies could commercially launch BAY 43-9006, which has been renamed sorafenib, in 2006, said Leonard Post, Onyx's senior vice president of R&D.

The companies' decision to move forward with the NDA follows a review of the pivotal study's safety and efficacy data by an independent data monitoring company, which determined that the study met its primary endpoint, Renton said. The trial showed that patients taking sorafenib had longer progression-free survival than patients taking a placebo.