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GEN News Highlights : Jul 1, 2010

Phase III Data Shows Novartis’ Afinitor More Than Doubles PFS in Pancreatic NET Patients

Trial also demonstrated that the drug reduced risk of cancer progression by 65%.

Treating advanced pancreatic neuroendocrine tumors (NET) using Novartis’ Afinitor® more than doubles progression-free survival (PFS) in comparison with placebo, according to new Phase III trial data. Novartis has previously confirmed it plans worldwide Afinitor regulatory filings for this indication later this year.

The Radiant-3 study involving 410 pancreatic NET patients showed that treatment using Afinitor in addition to best supportive care (BSC) boosted median progression-free survival from 4.6 months to 11 months when compared with treatment using placebo plus BSC. The data also showed that Afinitor reduced the risk of cancer progression by 65%.

Novartis says that additional data from the pivotal study are due for presentation at the "35th European Society for Medical Oncology Congress" in Italy later this year.

Afinitor is already available in the EU and U.S. as a treatment for advanced renal cell carcinoma in paitents who have previously received other approved therapeutics. Afinitor’s active ingredient everolimus is separately available in the EU as Certican® and in the U.S. as Zortress® for the prevention of organ rejection in heart and/or kidney transplant patients.