NEW YORK (AP) – AstraZeneca PLC said December 2 that a Food and Drug Administration panel made a positive recommendation on vandetanib, a drug the company is developing as a treatment for a rare type of thyroid cancer.
The panel said there are patients who might benefit enough from vandetanib to justify the risks associated with the drug. The advisory panel also recommended that AstraZeneca be required to run another study that would evaluate other doses of vandetanib if the drug is approved. The FDA is not required to follow the advice of its panels, but it often does. The agency is scheduled to make a decision on vandetanib by Jan. 7.
The British drugmaker is seeking approval for vandetanib as a treatment for inoperable medullary thyroid cancer that has either metastasized or advanced locally. AstraZeneca originally applied for approval of the drug in June 2009 under the name Zactima. But it withdrew those applications in October of that year, saying regulatory agencies were not likely to approve the drug in the U.S. and Europe, and studies showed it did not improve survival when added to chemotherapy.
The company said medullary thyroid cancer accounts for about 4 percent of all thyroid cancers, and there are no approved treatment options for patients with advanced disease. It said around 44,000 cases will be diagnosed in the U.S. this year.
Date: December 2, 2010
Source: The Associated Press
