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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

is 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(1).

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(1).

"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."

About renal cell carcinoma

Renal cell carcinoma is often referred to as kidney cancer. Kidney cancer accounts for approximately 2% of all new cancers(4). RCC is the most common type of kidney cancer, with occurrence rates rising steadily around the world due in part to smoking and obesity(5,6). It is estimated that about 54,000 new cases of RCC developed in the US in 2008 and more than 13,000 people died from the disease(7).

In RCC, cancer cells develop in the lining of the kidney's tubes and grow into a tumor(8). If left untreated, the tumor can spread to neighboring lymph nodes and eventually other organs(9).

RECORD-1 trial
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SOURCE Novartis Pharmaceuticals Corporation
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