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Zactima Granted Orphan-Drug Designation, Investigational Treatment for Thyroid Cancer

WILMINGTON, Del., Oct. 31 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE:AZN) announced today that the U.S. Food and Drug Administration (FDA) granted orphan-drug designation for ZACTIMA(TM) (ZD6474) for the treatment of patients with follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer. ZACTIMA is designed to be a multitargeted compound, directed to the inhibition of key cell signaling pathways involved in tumor growth and spread. Tumor cells are targeted through inhibition of epidermal growth factor receptor (EGFR) and RET tyrosine kinases, while tumor blood supply is targeted through inhibition of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase. RET tyrosine kinase activity is an important growth driver in certain thyroid tumors.

"AstraZeneca has been dedicated to the fight against cancer for over 30 years," said Peter Langmuir, MD, Senior Director, Medical Science, AstraZeneca. "We are committed to delivering medicines that extend and improve the lives of people with cancer, and we are pioneering the development of novel medicines to treat many types of cancer."

ZACTIMA is an investigational drug being evaluated in Phase II clinical trials in medullary thyroid cancer and Phase III clinical trials in advanced non-small-cell lung cancer.

Orphan-drug designation was designed to promote the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions, specifically, those that affect less than 200,000 people in the United States. ZACTIMA is the first oncology orphan-drug designation AstraZeneca has received.

According to the American Cancer Society, nearly 26,000 people in the United States will be diagnosed with thyroid cancer this year. Current treatments for thyroid cancer include surgery, radioactive iodine, hormone treatment, external radiation or chemotherapy.

AstraZeneca is currently enrolling patients in a ZACTIMA study in locally advanced or metastatic hereditary medullary thyroid cancer at Duke University in Durham, NC. For more information on this trial, please call 919-668-3533. For more information about AstraZeneca, please visit:

Source: AstraZeneca

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