February 9, 2006

The FDA has granted fast-track designation to AstraZeneca's experimental thyroid cancer drug Zactima, according to the firm that also reported higher earnings in the last quarter.

Fast-track designation is intended to expedite the review of an investigational drug that treats serious or life-threatening conditions and that demonstrates the potential to address unmet medical needs. There currently is no cure or approved chemotherapy for advanced thyroid cancer, AstraZeneca said recently.

Zactima is being evaluated in Phase II clinical trials for the treatment of medullary thyroid cancer. Phase III clinical trials for the treatment of advanced non-small-cell lung cancer are scheduled in the near future, the firm said. Zactima is being studied as a multitargeted compound that inhibits key cell-signaling pathways involved in tumor growth and spread.

Last fall, the FDA granted Zactima orphan-drug status for the treatment of patients with various types of thyroid cancer. Orphan-drug status is granted to drugs that treat diseases with less than 200,000 patients in the U.S., and gives a firm seven years of market exclusivity.