Singapore, Jun 3, 2009: Novartis announced that Afinitor (everolimus) has been approved by the Food and Drug Administration (FDA) for patients with advanced kidney cancer, or renal cell carcinoma (RCC), after failure of treatment with Sutent (sunitinib) or Nexavar (sorafenib), the commonly used initial treatments for advanced RCC. Prior to Afinitor, no other therapy has been studied in a Phase III trial among RCC patients.

Dr Tay Miah Hiang, consultant at OncoCare Cancer Centre at Gleneagles Medical Centre and visiting consultant at the National Cancer Center is taking these global findings a step further by conducting a phase III clinical trial in Singapore on a combination of Afinitor and Avastin, a FDA-approved anti-tumor treatment.

“The reason for the clinical trial is to establish the efficacy of Afinitor with another effective drug in the treatment of patients with advanced kidney cancer. The outcome of the study, together with the milestone FDA endorsement, could play a major role in better cancer control, and ultimately give local RCC patients one more option in treating this disease,” said Dr Tay.

Afinitor inhibits mTOR, a protein in the cancer cell that controls tumor cell division and blood vessel growth. Preclinical and clinical data have established the important role of mTOR in the development and progression of several types of tumors.

“With FDA approval, we can now offer patients a targeted therapy proven to fulfill an important unmet need2 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,” said David Epstein, President and CEO, Novartis Oncology, Novartis Molecular Diagnostics.

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 vs. 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, 2/4 additional data shows 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 European Union, Japan, Singapore and Switzerland, as well as with other regulatory agencies globally.