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FDA Grants Fast Track Designation on Zactima for the Treatment of Thyroid Cancer

WILMINGTON, Del., Feb. 2 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE:AZN) announced today during their Fourth Quarter and Full Year Results meeting that the US Food and Drug Administration (FDA) has granted fast track designation for the investigation of ZACTIMA(TM) (ZD6474) in treating medullary thyroid carcinoma. For advanced thyroid cancer, there is currently no curative modality or approved chemotherapy. ZACTIMA also received orphan-drug designation last year for the treatment of patients with follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer.

"We are pleased to receive fast track designation for ZACTIMA for the treatment of medullary thyroid cancer, and are committed to evaluating the potential of ZACTIMA as a new treatment option for patients with this disease," said Peter Langmuir, MD, Senior Director, Medical Science, AstraZeneca.

The fast track designation provides AstraZeneca certain benefits that may facilitate the drug development and regulatory submission processes, including the opportunity to seek FDA input into development plans, the option of a rolling submission of the New Drug Application (NDA), and the option of requesting evaluation of studies using surrogate endpoints. This designation is intended to facilitate the development and expedite the review of investigational drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

ZACTIMA is being evaluated in a Phase II clinical trial in medullary thyroid cancer, and AstraZeneca is currently enrolling patients in a single arm Phase II ZACTIMA study in locally advanced or metastatic hereditary medullary thyroid cancer. For more information on this trial, please call the AstraZeneca Cancer Support Network at 1-866-992-9276. Phase III clinical trials in another tumor type, advanced non-small-cell lung cancer, are scheduled to start in the near future.

ZACTIMA is being studied as 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 REarranged during Transfection (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.

About Thyroid Cancer
According to the American Cancer Society, nearly 26,000 people in the United States were diagnosed with thyroid cancer in 2005. Medullary thyroid cancer is a specific form of thyroid cancer that comprises 5-10 percent of all thyroid cancers. Current treatments for thyroid cancer include surgery, radioactive iodine, hormone treatment, external radiation or chemotherapy.

Source: AstraZeneca

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