FDA approves Bayer/Onyx kidney cancer drug

Share this article:
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.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.