AstraZeneca has submitted a New Drug Application to the FDA and a Marketing AuthorisationApplication (MAA) to the European Medicines Agency (EMEA) for aninvestigational drug, vandetanib 100 mg for use in combination withchemotherapy for the treatment of advanced non-small cell lung cancer inpatients previously treated with one prior anti-cancer therapy. The U.S. andEuropean submissions are supported by data from Phase III clinical studiesevaluating the safety and efficacy of vandetanib 100 mg in combination withchemotherapy. Pending approval, the treatment will be marketed asZACTIMA(TM). Evaluation of vandetanib is ongoing, as monotherapy or in combination withother anti-cancer therapies in a range of tumour types, including thyroidcancer. Results from the ZEPHYR (300mg monotherapy study in EGFR failures inadvanced NSCLC, Phase III) and ZETA (300 mg monotherapy in advanced medullarythyroid cancer, Phase III) studies will be presented in the first half of2010. Howard Hutchinson, MD, Chief Medical Officer at AstraZeneca said, “Lungcancer is an area of high unmet need and these submissions are an importantstep toward potentially broadening the treatment options available forpatients.”
