CHMP Recommends Novartis' EU Approved Afinitor For Patients With Advanced Kidney Cancer
Published: 29-May-2009
Novartis has received a positive response from the Committee for Medicinal Products for Human Use (CHMP), supporting European Union (EU) approval of Afinitor (everolimus) tablets for the treatment of patients with advanced renal cell carcinoma (RCC).
CHMP has recommended the approval of Afinitor based on data demonstrating that (when compared with placebo) Afinitor more than doubled the time without tumor growth or death in patients with advanced kidney cancer, whose disease progressed following prior therapy. Additionally, the data showed that Afinitor reduced the risk of disease progression or death by 67%.
David Epstein, President and CEO of Molecular Diagnostics at Novartis Oncology, said: This positive opinion is good news for those living with advanced kidney cancer and puts us one step closer to offering these patients a new treatment choice that will fulfill an important unmet medical need.
We also are studying the role of Afinitor for early kidney cancer, as well as its potential as a treatment for other tumor types, he added.
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