FDA Grants Fast-Track Designation to ZD6474 for Thyroid Cancer

The US Food and Drug Administration (FDA) has granted fast-track designation for the investigation of ZD6474 (Zactima) in treating medullary thyroid carcinoma. For advanced thyroid cancer, there is currently no curative modality or approved chemotherapy. ZD6474 also received orphan drug designation last year for the treatment of patients with follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer.

The fast-track designation is intended to facilitate the development and expedite the review of investigational drugs being developed to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

ZD6474 is being studied as a multitargeted compound, directed to the inhibition of key cell-signaling pathways involved in tumor growth and spread. The drug 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 study in locally advanced or metastatic hereditary medullary thyroid cancer. For more information on this trial, call the AstraZeneca Cancer Support Network at 1-866-992-9276. Phase III clinical trials in advanced non-small-cell lung cancer are scheduled to start in the near future.