AstraZeneca ($AZN) has won an expert panel's backing for vandetanib, a treatment for a rare type of thyroid cancer, called inoperable medullary thyroid cancer, which has locally advanced or metastasized. Though FDA staffers were concerned about the risk of high levels of toxicity faced by prospective patients, the panel determined those risks were justified given the potential benefit to patients. If approved, the panel unanimously recommended that AstraZeneca conduct a post-approval study to evaluate other doses of the drug.
"Patients with advanced medullary thyroid cancer face an unmet medical need since there is no medicine approved to treat this disease. Based on the clinical trial results we have seen with vandetanib, we believe it has the potential to provide appropriate patients and their doctors with an important treatment option," said Dr. Howard Hutchinson, AstraZeneca's CMO.
Originally hailed as a highly-anticipated blockbuster, AstraZeneca was forced to narrow Vandetanib's focus after it failed to extend the survival rate of lung cancer victims. Inoperable medullary thyroid cancer accounts for just four percent of the 44,000 cases of thyroid cancer diagnosed each year. Analysts predict peak sales of the drug to hit $100 million. The FDA will make it's final decision on January 7.
- here's AstraZeneca's release
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