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AstraZeneca Submits New Drug Applications for ZACTIMA(TM) in Second-Line Advanced Non-Small Cell Lung Cancer
Date:7/30/2009

WILMINGTON, Del., July 30 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced the company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for an investigational drug, vandetanib 100 mg for use in combination with chemotherapy for the treatment of advanced non-small cell lung cancer in patients previously treated with one prior anti-cancer therapy. The U.S. and European submissions are supported by data from Phase III clinical studies evaluating the safety and efficacy of vandetanib 100 mg in combination with chemotherapy. Pending approval, the treatment will be marketed as ZACTIMA(TM).

Evaluation of vandetanib is ongoing, as monotherapy or in combination with other anti-cancer therapies in a range of tumour types, including thyroid cancer. Results from the ZEPHYR (300mg monotherapy study in EGFR failures in advanced NSCLC, Phase III) and ZETA (300 mg monotherapy in advanced medullary thyroid cancer, Phase III) studies will be presented in the first half of 2010.

Howard Hutchinson, MD, Chief Medical Officer at AstraZeneca said, "Lung cancer is an area of high unmet need and these submissions are an important step toward potentially broadening the treatment options available for patients."

About Vandetanib

Vandetanib has a unique profile that fights cancer through two clinically proven mechanisms -- by blocking the development of tumour blood supply (anti-angiogenesis or anti-VEGFR), and by blocking the growth and survival of the tumour itself (anti-EGFR). Vandetanib also inhibits RET-tyrosine kinase activity, an important growth driver in certain types of thyroid cancer.

About Vandetanib Phase III Studies'/>"/>

SOURCE AstraZeneca
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