SuperGen Inc announced that the Food and Drug Administration has designated Orathecin (rubitecan) oral for pancreatic cancer as a 'fast track' product for the treatment of patients with locally advanced or metastatic pancreatic cancer that is resistant or refractory to chemotherapies.
Under the FDA Modernization Act of 1997, designation as a 'fast-track' drug means that the FDA will facilitate and expedite the development and review of the application for the approval of a new drug, if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need.
"We are very pleased that the FDA has granted our upcoming Orathecin New Drug Application (NDA) a 'fast track' designation," said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen. "Given the lack of effective treatment options for pancreatic cancer, by far the most lethal of all cancers, we believe that our upcoming filing clearly targets an unmet medical need. Indeed, demonstration of efficacy should be an important breakthrough in the treatment of pancreatic cancer."
The company recently announced that it is scheduled to begin the Orathecin NDA filing by year-end and complete the process in Q1 2003. The company also announced its current intention to announce the results from the Phase III clinical program of Orathecin next May at the 2003 annual meeting of the American Society of Clinical Oncology (ASCO), the largest and most prestigious gathering of cancer experts in the world.
Pancreatic cancer is associated with high patient mortality causing more than 75,000 deaths annually worldwide. It is the fourth-leading cause of death by cancer in the United States, with an average one-year survival rate of less than 5 per cent.