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Pharmaceutical

FDA Seeks More Time for Vandetanib Review

January 11, 2011
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According to the Associated Press, AstraZeneca PLC said the U.S. Food and Drug Administration will take three more months to review the British company''s application for vandetanib, a drug it is developing as a treatment for a rare type of thyroid cancer. AstraZeneca said that it has submitted a risk evaluation and mitigation strategy at the FDA''s request, and the agency needs the additional time to review it. The FDA has extended its review completion date from January 7 to April 7. AstraZeneca is seeking approval for vandetanib as a treatment for inoperable medullary thyroid cancer that has either metastasized or advanced locally. In December, an FDA panel made a positive recommendation on the drug candidate. The FDA is not required to follow the advice of its panels, but it often does. AstraZeneca originally applied for approval of the drug in June 2009 under the name Zactima as a drug to be used in conjunction with chemotherapy to treat advanced non-small cell lung cancer. But it withdrew those applications in October 2009, saying U.S. and European regulatory agencies were unlikely to approve the drug after studies failed to show it improved survival when added to chemotherapy.

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