Novartis wins FDA approval for kidney cancer drug

Novartis has received FDA approval for Afinitor tablets for patients with advanced renal cell carcinoma after failure of treatment with Sutent or Nexavar.

The approval is based on data that showed Afinitor, when compared with placebo, more than doubled the time without tumor growth or death in patients with advanced kidney cancer (4.9 versus 1.9 months) and reduced the risk of disease progression or death by 67% (hazard ratio=0.33 with 95% confidence interval 0.25 to 0.43; P<0.0001). Furthermore, additional data show that after 10 months of treatment with Afinitor, approximately 25% of patients still had no tumor growth. 

In 2008, the FDA granted priority review status to Afinitor, previously known as RAD001, based on its potential to fill an unmet medical need for patients with advanced kidney cancer. Novartis has filed regulatory submissions in the EU, Switzerland and Japan, as well as with other regulatory agencies globally.

David Epstein, president and CEO of Novartis Oncology, Novartis Molecular Diagnostics, said: With this approval, we can now offer patients a targeted therapy proven to fulfill an important unmet need in the treatment of advanced kidney cancer. We continue to study Afinitor in kidney cancer, and through a broad clinical program to explore its potential in many other tumor types.