AstraZeneca’s Zactima (ZD6474) has been granted orphan drug status in the USA for the treatment of certain rare forms of thyroid cancer
Zactima is currently being developed in a Phase II clinical trial in medullary thyroid cancer and Phase III clinical trials in advanced non-small cell lung cancer are scheduled to start in the next few months.
In the USA, orphan drug status can be given to drugs with a treatment population of less than 200,000 patients. It can reduce the amount of efficacy data required to before approval, speeding up the time to market. Zactima has been named an orphan drug for follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer in the USA. It already has this status in Europe.
Zactima is an orally active, once daily treatment that blocks growth factors involved in tumour spread (VEGF and EGF) as well as RET kinase, which drives the growth and survival of certain cancers, said AstraZeneca.