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A new drug from AstraZeneca to treat a rare form of thyroid cancer, that can be fatal when it spreads to other parts of the body, was approved by federal health regulators last week.
The Food and Drug Administration (FDA) approved the drug, called vandetanib, for medullary thyroid cancer that cannot be treated with surgery and is growing or causing symptoms. The disease begins with a cancerous growth in the neck which leads to excessive levels of important hormones secreted by the thyroid gland.
Nearly all patients can expect to live at least five years after being diagnosed with the disease, but survival decreases dramatically if the cancer spreads to other parts of the body.
Symptoms include coughing, difficulty swallowing, swelling of the thyroid gland and changes in a person’s voice.
“Vandetanib’s approval underscores FDA’s commitment to approving treatments for patients with rare and difficult to treat diseases,” said Dr Richard Pazdur, director of the FDA’s cancer drugs division.
The FDA approved the drug based on a 331-patient study that showed patients on the drug typically lived six months longer without seeing their disease progress than patients taking a placebo.
AstraZeneca originally applied for approval of the drug in June 2009 under the name Zactima. But it withdrew the application in October of that year, saying regulatory agencies were not likely to approve the drug in the U.S. and Europe, and studies showed it did not improve survival when added to chemotherapy.
Copyright © Press Association 2011