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Latest RAD001 Study Results Show Further Increase in Time Without Tumor Growth in Patients With Advanced Kidney Cancer
Date:9/15/2008

ncer after failure of standard treatment, including Sutent(R) (sunitinib) or Nexavar(R) (sorafenib), or both.

Earlier this year, interim results from RECORD-1 presented at the American Society of Clinical Oncology Congress were used to submit regulatory applications for RAD001 as a treatment for metastatic renal cell carcinoma (RCC). RAD001 was granted priority review by the US Food and Drug Administration. FDA priority review status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review time from ten to six months.

"We are encouraged by the continued benefit RAD001 provided to patients with advanced kidney cancer in this trial," said David Epstein, CEO and President of Novartis Oncology. "Novartis is committed to bringing this new, innovative therapy to market and to exploring the potential of RAD001 beyond this specific treatment setting."

RAD001 is a once-daily oral therapy that may offer a new approach to cancer treatment by continuously inhibiting the mTOR protein, a central regulator of cell division and tumor blood vessel growth. Data suggest RAD001 has clinical activity as a single agent or in combination with other therapies in multiple types of cancer, including pancreatic neuroendocrine tumors, breast, gastric, lung and lymphoma.

RECORD-1 results

RECORD-1 is the largest Phase III clinical trial investigating the effects of an oral mTOR inhibitor in metastatic RCC. It is a randomized, double-blind, placebo-controlled multicenter trial of more than 400 patients with RCC whose cancer worsened despite prior treatment including Nexavar or Sutent, or both. In addition, prior therapy with Avastin, interferon and interleukin-2 was allowed.

The primary endpoint of RECORD-1 was progression-free survival (PFS) assessed via a blinded, independent central review and defined as the amount of time between randomization and first documented disease progression or dea
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SOURCE Novartis Pharmaceuticals Corporation
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