Kidney Cancer

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

Published in Cancer Weekly, September 23rd, 2008

Novartis announced 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...

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Source: Cancer Weekly (2008-09-23)

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