Company says mTOR inhibitor is first new treatment for this indication in nearly 30 years.

FDA has approved Novartis’ Pharmaceuticals’ Afinitor® tablets for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced, or metastatic disease. The firm says the approval is the first in nearly 30 years for a new treatment in this patient population.

FDA clearance of Afinitor was based on data from the placebo-controlled Phase III Radiant-3 study in 410 patients with advanced, low- or intermediate-grade pancreatic NET. The results showed that treatment using Afinitor in addition to best supportive care (BSC) more than doubled time to tumor growth to 11 months and reduced the risk of cancer progression by 65%, in comparison with BSC and placebo. Afinitor therapy was also associated with a consistent improvement in progression-free survival.   

Approval of Afinitor for the pancreatic NET indication is the third for the mTOR inhibitor in two years, Novartis notes. The drug is currently approved in various markets including the U.S. for the treatment of patients with renal cell carcinoma.

In 2010 the drug was cleared by FDA for the treatment of subependymal giant cell astrocytomas, a benign brain tumor associated with tuberous sclerosis. Regulatory submissions have been filed in the EU for this indication under the trade name Votubia. Novartis reported Afinitor sales of $243 million in 2010.

Afinitor is in addition marketed in the U.S. and other countries under the trade names Zortress and Certican for use in the prevention of organ rejection in adult kidney and heart transplant patients. Sales of Zortress/Certican reached $144 million in 2010, up 25% compared with 2009.

Also, the drug is being studied in late-stage clinical trials against a range of other cancers including advanced breast cancer.

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