The US Food and Drug Administration has granted fast track designation to for the investigation of AstraZeneca's Zactima (ZD6474) in treating medullary thyroid carcinoma.

Zactima also received orphan-drug designation last year for the treatment of patients with follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer, claims the company release.

"We are pleased to receive fast track designation for Zactima for the treatment of medullary thyroid cancer, and are committed to evaluating the potential of Zactima as a new treatment option for patients with this disease," said Peter Langmuir, senior director, medical science, AstraZeneca.

The fast track designation provides AstraZeneca certain benefits that may facilitate the drug development and regulatory submission processes, including the opportunity to seek FDA input into development plans, the option of a rolling submission of the new drug application (NDA), and the option of requesting evaluation of studies using surrogate endpoints. This designation is intended to facilitate the development and expedite the review of investigational drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Zactima is being evaluated in a phase II clinical trial in medullary thyroid cancer, and AstraZeneca is currently enrolling patients in a single arm phase II Zactima study in locally advanced or metastatic hereditary medullary thyroid cancer.

According to the American Cancer Society, nearly 26,000 people in the United States were diagnosed with thyroid cancer in 2005. Medullary thyroid cancer is a specific form of thyroid cancer that comprises 5-10 per cent of all thyroid cancers.