Breaking News, Trials & Filings

Wyeth Submits NDA and MAA for Cancer Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Wyeth Pharmaceuticals has submitted an NDA to the FDA and a marketing authorization application (MAA) to the EMEA for Torisel for the treatment of patients with advanced renal cell carcinoma (RCC). The registration dossier contains interim data from a Phase III trial of 626 patients who had received no prior systemic therapy. The primary end point of the study was overall survival. The results showed treatment with Torisel increased median survival by 3.6 months, or 49%, compared with treat...

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