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Published on 31 March 2009

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Novartis announce approval of Afinitor tablets

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Novartis announced today that Afinitor (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 (sunitinib) or Nexavar (sorafenib).

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. Sutent and Nexavar are commonly used as initial treatments for advanced RCC.

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

“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, attending physician, Memorial Sloan-Kettering Cancer Center, New York and principal investigator of the RECORD-1 trial, the basis for FDA approval of Afinitor.

“New treatment options are vital to help us continue to offer patients with advanced kidney cancer new ways to battle their difficult-to-treat disease. Based on clinical trial data, this option should be considered when sunitinib or sorafenib fail.”

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, Switzerland and Japan, as well as with other regulatory agencies globally.

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 this approval, we can now offer patients a targeted therapy proven to fulfill an important unmet need in the treatment of advanced kidney cancer,” said David Epstein, President and CEO, Novartis Oncology, Novartis Molecular Diagnostics.

“We continue to study Afinitor in kidney cancer, and through a broad clinical program to explore its potential in many other tumor types.”

Novartis



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