AstraZeneca's Zactima for thyroid cancer obtains FDA Fast Track designation

By Lisa Kerner

Erie, Pa., Feb. 2 - AstraZeneca said the Food and Drug Administration has granted Fast Track designation for the investigation of Zactima (ZD6474) in treating medullary thyroid carcinoma.

The Fast Track designation is intended to facilitate the development and expedite the review of

investigational drugs aimed at serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs, according to a company news release.

Zactima is being studied as a multitargeted compound, directed to the inhibition of key cell signaling pathways involved in tumor growth, the company said.

Zactima is being evaluated in a phase 2 clinical trial in medullary thyroid cancer, and AstraZeneca is currently enrolling patients in a single arm phase 2 Zactima study in locally advanced or metastatic hereditary medullary thyroid cancer.

Zactima received orphan-drug designation last year for the treatment of patients with follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer. The company said there is currently no curative modality or approved chemotherapy for advanced thyroid cancer.

Phase 3 clinical trials in another tumor type, advanced non-small-cell lung cancer, are scheduled to start in the near future.

AstraZeneca is a pharmaceutical and health care services company based in London.

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