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Thyroid problem news from Thyroid Talk GET A FREE COPY OF THIS GREAT e-BOOK BELOW FOR A LIMITED TIME. AstraZ's thyroid-cancer drug fast tracked WASHINGTON, Feb. 2 (UPI) -- AstraZeneca said Thursday that its thyroid-cancer drug Zactima has been granted fast-track review. The company is seeking Food and Drug Administration approval of the drug to treat medullary thyroid carcinoma. There is no currently approved chemotherapy for advanced forms of the disease, AstraZeneca said. The FDA grants fast-track status to drugs that treat serious diseases for which there is an unmet medical need and the drug represents an advancement over existing therapies. Fast-track status gives sponsors perks including the possibility to rely on abbreviated, "surrogate" endpoints, rather than fully developed endpoints to show the drug's safety and efficacy and a likely six-month review. Zactima also got orphan-drug status designation last year for the treatment of patients with follicular, medullary, anaplastic and locally advanced and metastatic papillary thyroid cancer. Orphan-drug status is reserved for drugs for rare diseases that affect fewer than 200,000 people. The designation gives drug sponsors incentives to develop the low-profit treatments, including up to seven years' market exclusivity. Back to main Thyroid news page <<
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