AstraZeneca has submitted an NDA to the FDA for 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 company also submitted an MAA to the EMEA for the drug. If approved, the treatment will be marketed as Zactima.
Evaluation of vandetanib is ongoing as a monotherapy or in combination with other anti-cancer therapies in a range of tumor 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.
According to AZ, Vandetanib has a unique profile that fights cancer through two clinically proven mechanisms: by blocking the development of tumor 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.
Howard Hutchinson, M.D., AZ's chief medical officer, commented, "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."
See AZ's profile in this year's Top 20 Pharma Report!
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