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FDA Clears AstraZeneca Medullary Thyroid Cancer Drug
- Publisher：
- Publication：2011/4/11
AstraZeneca has received approval from the US Food and Drug Administration (FDA) for vandetanib as a treatment for late-stage medullary thyroid cancer in adults who are ineligible for surgery and whose disease is growing or causing symptoms.
Vandetanib is the first FDA-approved drug for medullary thyroid cancer.
The safety and effectiveness of vandetanib were proved in a single randomised and international study of 331 patients with late-stage medullary thyroid cancer, who were selected to receive vandetanib or a placebo.
The study was designed to evaluate the progression-free survival, and revealed that patients receiving vandetanib had a longer period of time without disease progression compared to patients receiving placebo.
Median progression-free survival was 16.4 months for patients 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.
Richard Pazdur, director of oncology drug products at the FDA's Center for Drug Evaluation and Research Office, said that Vandetanib's approval underscores the FDA's commitment to approving treatments for patients with rare and difficult-to-treat diseases.
Thyroid cancer is a cancerous growth of the thyroid gland. Medullary thyroid cancer involves specific types of cells that are found in the thyroid gland, which can occur spontaneously or may be part of a genetic syndrome.
Source: pharmaceutical-technology