AstraZeneca Submits New Drug Applications For Vandetanib To FDA

AstraZeneca has submitted a New Drug Application to the FDA, and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for an investigational drug – vandetanib 100mg.

Vandetanib, 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.

Reportedly, the US and European submissions are supported by data from phase III clinical studies, evaluating the safety and efficacy of vandetanib 100mg in combination with chemotherapy. Pending approval, the treatment will be marketed as ZACTIMA.

Howard Hutchinson, CMO 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.