Mayer Fishman, MD, Ph.D.

FDA Approves New Treatment for Advanced Kidney Cancer,

Providing Important Option for Thousands of Patients

Leading Oncologist Available to Discuss New Treatment Option

In the US, an estimated 54,000 people were diagnosed with kidney cancer in 2008. A new treatment, Afinitor® (everolimus) tablets, has just been approved by the US Food and Drug Administration (FDA) as the first treatment for patients with advanced kidney cancer after failure of treatment with Sutent® (sunitinib)* or Nexavar® (sorafenib)**, providing clinicians with an important new treatment. Sutent and Nexavar are commonly used as initial treatments for advanced kidney cancer.

The once-daily oral treatment, which was given priority review by the FDA after it demonstrated that it filled an unmet medical need in patients when therapy with Sutent or Nexavar failed, works by blocking mTOR, a key protein inside the cell that is responsible for tumor cell division and blood vessel growth.

Experts say that when compared to placebo in clinical trials, the drug significantly reduced the risk of disease progression, more than doubling the time without tumor growth or death in patients with advanced kidney cancer whose disease had progressed despite prior treatment with sunitinib, sorafenib, or both sequentially.

Mayer Fishman, MD, PhD, Associate Professor, H. Lee Moffitt Cancer Center & Research Institute, one of the nations leading oncologists discusses the importance of this new therapy and the role of mTOR inhibition in the treatment of advanced kidney cancer.

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