FDA gives orphan status to bile duct cancer drug
The FDA has granted Exelixis, a genomics-based drug discovery company from South San Francisco, CA, orphan drug designation to Exelixis' XL119, an experimental treatment for bile duct tumors.
The FDA has granted Exelixis, a genomics-based drug discovery company from South San Francisco, CA, orphan drug designation to Exelixis' XL119, an experimental treatment for bile duct tumors.
The company anticipates initiating a Phase III clinical trial for XL119 in this indication in the second quarter of 2004. Orphan drug status is granted to treatments for diseases that affect fewer than 200,000 people in the US and provides benefits including extended market exclusivity for seven years.
Dr George Scangos, president and chief executive officer commented: 'For the 30,000 people worldwide who develop bile duct cancer each year and for whom there are currently no approved therapies, we are hopeful that XL119 will prove beneficial. We are appreciative of the support provided by the FDA for developing potential treatments in orphan indications.'
The company also intends to continue to work with the National Cancer Institute in planning additional Phase II exploratory studies of XL119 in various tumor types where the compound may demonstrate potential benefit. The company may also consider applying for European orphan drug designation for XL119 following the commencement of the Phase III clinical trial in Europe.