FDA OKs Novartis' Pancreatic Tumor Drug - Drug Discovery and Development

The U.S. Food and Drug Administration (FDA) approved Novartis’ drug Afinitor for treating patients with advanced neuroendocrine tumors originating in the pancreas.

The approval was based on data from a drug trial that showed Afinitor more than doubled the time patients went without tumor growth. It also was found to reduce the risk of cancer progression by 65% compared with patients taking placebo. The move represents the first approval of a treatment for this condition in the United States in nearly 30 years.
Afinitor is approved as a treatment for advanced kidney cancer, as well as for children and adults with a benign brain tumor associated with tuberous sclerosis, a rare genetic disorder, which causes tumors in the brain, eyes, lungs, liver and other organs.

Neuroendocrine tumors (NET) – mostly found in the pancreas, gastrointestinal tract or lungs, have limited treatment options for patients with the disease. When pancreatic NET becomes advanced, it is considered aggressive and difficult to treat. About 60% of pancreatic NET patients are diagnosed with advanced disease, and the five-year survival rate for these patients is 27%.Afinitor tablets, taken once a day, target mTOR, a protein that regulates the growth of tumor cells and the blood vessels that feed them. “With this approval, U.S. physicians can now offer their patients with progressive pancreatic NET a new treatment helping to fulfill a critical unmet need,” said Herve Hoppenot, president of Novartis Oncology.

Release Date: May 5, 2011
Source: Novartis