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Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib
Date:3/30/2009

- Afinitor more than doubled time without tumor growth and reduced the risk of disease progression or death by 67% compared with placebo

- Only once-daily oral cancer treatment to directly target mTOR, a protein inside the cell that controls tumor cell division and blood vessel growth

- Phase III trials underway to explore potential of Afinitor in multiple additional cancers

EAST HANOVER, N.J., March 30 /PRNewswire/ -- Novartis announced today that Afinitor(R) (everolimus) tablets has been approved by the US Food and Drug Administration (FDA) for patients with advanced renal cell carcinoma (RCC) after failure of treatment with Sutent(R) (sunitinib)* or Nexavar(R) (sorafenib)**.

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/novartis/36142

Prior to Afinitor, no other therapy has been studied in a Phase III trial in this patient population where there is an important unmet medical need(1). Sutent and Nexavar are commonly used as initial treatments for advanced RCC(2).

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)(3). Furthermore, additional data show that after 10 months of treatment with Afinitor, approximately 25% of patients still had no tumor growth(1) ***.

"This approval provides a new and useful tool for treating advanced renal cell cancer, representing an important step forward in managing this disease," said Robert J. Motzer, MD, attending physician, Memorial Sloan-Kettering Cancer Center, New York and principal investigator of the RECORD-1 trial, the bas
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SOURCE Novartis Pharmaceuticals Corporation
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