Sabtu, 07 Mei 2011


Afinitor (everolimus) For Rare Pancreatic Cancer Approved By FDA

Afinitor (everolimus), a medication for patients with PNET (progressive neuroendocrine tumors) in the pancreas whose tumor cannot be surgically removed or whose cancer has metastasized (spread), has been approved by the Food and Drug Administration (FDA).

Neuroendocrine tumors located in the pancreas are rare and grow slowly. According to the CDC, there are approximately 1,000 newly diagnosed cases annually in the USA.

Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, said:
"Patients with this cancer have few effective treatment option. afinitor  has demonstrated the ability to slow the growth and spread of neuroendocrine tumors of the pancreas."

The FDA reviewed data from a clinical trial involving 410 patients. They either had:
  • Late stage cancer - it had spread to other parts of the body (metastasis)
  • The tumor was locally advanced - it could not be surgically removed
Half of them were randomly selected to receive Afinitor while the other half were given a placebo (dummy drug). The trial's endpoint was progression-free survival - the aim was to measure how long patients lived before the disease started getting worse again.

Those on Afinitor had progression-free survival of 11 months, compared to 4.6 months for those on the placebo. The placebo patients whose disease worsened were given the option of swapping to the other group.

The most commonly reported side effects for Afinitor were stomatitis (inflammation of the mouth), rash,
fatigue, diarrhea, edema, abdominal pain, fever, headache and nausea.

Afinitor is already approved for treating advanced
renal cell carcinoma (kidney cancer) after the patient did not respond properly to Sutent or Nexavar. It is also administered to patients with a type of brain cancer (subependymal giant cell astrocytoma) whose tumor cannot be surgically removed.

Zortress, another trade name for Afinitor, is used as an immunosuppressant for kidney transplantation recipients.

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