الغذاء و الدواء تعتمد عقار”فانديتانيب” لعلاج سرطان الدرقيه

أعتمدت منظمة الغذاء و الدواء يوم الأربعاء عقار شركة أسترازينيكا “فانديتانيب” لعلاج سرطان الدرقيه للبالغين و يعتبر هذا هو الدواء الأول الذي يتم الموافقه عليه لعلاج هذا المرض.

The FDA on Wednesday approved AstraZeneca’s vandetanib for the treatment of adult patients with unresectable locally advanced or metastatic medullary thyroid cancer (MTC). The agency noted that the oral drug is the first product approved for this type of cancer in the US. “Vandetanib’s approval underscores FDA’s commitment to approving treatments for patients with rare and difficult to treat diseases,” commented Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

The decision, which follows an announcement in January that US regulators would extend their review of the drug, was based on data from the ZETA study, which randomised 331 patients with late-stage MTC to receive vandetanib or placebo. Data showed that median progression-free survival was at least 22.6 months in the vandetanib arm, compared to 16.4 months in the placebo arm.

Vandetanib is being approved with a risk evaluation and mitigation strategy warning that the drug can affect the electrical activity of the heart, which in some cases can cause irregular heart beats that could lead to death.

Analysts predict that AstraZeneca’s drug, which is also being studied for the treatment of other tumour types, will garner $82 million in sales in 2015.