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RAD001 Granted Priority Review in the US Based on Potential to Fill Unmet Medical Need in Patients With Advanced Kidney Cancer
Date:9/9/2008


-- Regulatory applications to be submitted worldwide for RAD001 first

submissions filed in the Hidden List US, EU and Switzerland

-- Data showing that RAD001 more than doubles time without tumor growth and

reduced risk of disease progression by 70% now published in The Lancet

-- RAD001 shows promise to become first once-daily oral therapy targeting

mTOR to treat advanced kidney cancer

EAST HANOVER, N.J., Sept. 9 /PRNewswire/ -- Novartis announced today that RAD001 (everolimus) has been granted priority review by the US Food and Drug Administration (FDA). The designation is based on the drug's potential to become the first therapy to demonstrate significant benefit in patients with advanced kidney cancer after failure of standard treatment.

Novartis has also filed marketing authorization applications for RAD001 with the European Medicines Agency (EMEA) and the Swiss Agency for Therapeutic Products (Swissmedic).

The regulatory submissions are based on data from the RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily) trial. Interim results from this study were published in The Lancet on July 23, 2008, and presented earlier this year at the annual meeting of the American Society of Clinical Oncology. The data show that after failure of standard treatment in patients with advanced kidney cancer, RAD001 more than doubled time without tumor growth and reduced the risk of disease progression by 70%.

"Currently, patients with advanced kidney cancer who have experienced treatment failure with standard therapies have limited options," said Alessandro Riva, MD, Vice President & Global Head of Development, Novartis Oncology. "The priority review designation for RAD001 brings us one step closer to offering these patients a promising new therapy."

FDA priority review status is granted to therapies that could potentially fill a currently unmet medi
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SOURCE Novartis Pharmaceuticals Corporation
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