AZ gets green light for thyroid cancer drug
pharmafile | April 7, 2011 | News story | Sales and Marketing | AstraZeneca, zactima
AstraZeneca’s Zactima has become the first treatment to be approved for a rare form of thyroid cancer.
The orphan drug was granted a US licence from the FDA on the back of phase III results showing statistically significant improvements versus placebo, and around six months additional progression-free survival.
Zactima (vandetanib) is a once-daily oral treatment for adult patients with late-stage non-operable medullary thyroid cancer that is spreading to other parts of the body.
Located in the neck, thyroid cancer is a cancerous growth found in the thyroid gland. Medullary thyroid cancer involves specific cell types in the gland and can occur as a result of genetic predisposition or spontaneously. The rare form of disease is estimated to represent 3-5% of all thyroid cancers.
“Vandetanib’s approval underscores FDA’s commitment to approving treatments for patients with rare and difficult to treat diseases,” said Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.
The drug is currently under regulatory review in Europe and the FDA’s decision will be welcomed by AZ, which was forced to withdraw Zactima’s original licence application in lung cancer after poor trial results.
Howard Hutchinson, chief medical officer at AstraZeneca, said: “Vandetanib is the only medicine to receive FDA approval specifically for use in patients with advanced medullary thyroid cancer and is the first treatment that AstraZeneca has developed and brought to market under orphan drug designation in the US.”
Brett Wells
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