Phase 3 Data Backs Novartis' Afinitor
Data published in the medical journal The Lancetshowed a significant reduction of kidney tumors due to tuberous sclerosis complex (TSC) in patients enrolled in a phase 3 trial of Novartis'drug Afinitor, the company announced in a press statement released Thursday.
TSC, a rare disease that Novartis says affects between 1 million and 2 million people across the globe, is a genetic disorder that can cause non-malignant tumors to grow in various parts of the body, including the kidneys. The EXIST-2 phase 3 trial for Afinitor showed a response rate of 42% of patients taking the drug, compared to 0% taking a placebo.
The findings are one more piece of data to support Afinitor, which has already received regulatory approval to treat these tumors in both the United States and European Union.
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