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news.The US Food and Drug Administration (FDA) has approved AstraZeneca's Vandetanib as a treatment for adult patients with late-stage medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms.
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Astrazeneca said the safety and effectiveness of Vandetanib were proved in a single randomised international study of 331 patients with late-stage medullary thyroid cancer, who were selected to receive vandetanib or placebo.
The study was designed to investigate the length of time a patient lived without the individual’s cancer progressing (progression-free survival).
The study results demonstrated that patients receiving Vandetanib had a longer period of time without disease progression when compared to patients receiving placebo.
Median progression-free survival was 16.4 months in the placebo arm, while it was at least 22.6 months in the Vandetanib arm.
Vandetanib is to be administered orally on a daily basis.
Vandetanib works by targeting the medullary thyroid cancer’s ability to grow and expand.
FDA Center for Drug Evaluation and Research Office Oncology Drug Products director Richard Pazdur said Vandetanib’s approval underscores FDA’s commitment to approving treatments for patients with rare and difficult to treat diseases.