FDA approves Bayer/Onyx kidney cancer drug
Bayer announced today that it has won FDA approval for its Nexavar (sorafenib) advanced kidney cancer drug, co-developed with Onyx Pharmaceuticals.
Nexavar is the first FDA-approved product for kidney cancer in more than a decade, the agency said.
Prior to the approval, Bayer said it did not expect regulatory approval for the drug until the first half of 2006. Bayer is expected to begin shipping Nexavar, primarily to specialty pharmacies, within the next 24 hours.
"The FDA approval of Nexavar is a crucial step for patients with advanced kidney cancer therapy," chief executive Werner Wenning said in a statement. " . . . Thanks to the rapid granting of approval, we will now be able to make this urgently needed product available earlier than planned."
According to Bayer, Nexavar has been shown to double "progression-free" survival in patients with kidney cancer.