SuperGen Inc has begun submission of a New Drug Application (NDA) for its anticancer compound Orathecin, an oral chemotherapy compound in the camptothecin class, for the treatment of pancreatic cancer patients who are refractory (resistant) to available therapies. The submission will occur on a 'rolling' basis and is expected to be completed by the end of the first-quarter of 2003. The first module submitted contained the chemistry, manufacturing and controls (CMC) section.
The NDA submission will contain data on over 2,700 patients treated under Orathecin study protocols and will be based on the company's Phase III clinical program, the largest randomized pancreatic cancer program ever initiated worldwide. The submission will also be supported by data from a Phase II clinical study of Orathecin in refractory pancreatic cancer. The Phase II data were presented at the 2000 Annual Meeting of the American Society of Clinical Oncology (ASCO) and were reviewed by an independent third- party expert radiology review panel.
"The beginning of this submission is extremely gratifying for myself and all of our team members who have dedicated themselves to this program for more than five years," said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen. "More importantly, in a disease with a fatality rate of 98 per cent, there is a screaming need for new therapies and we are now one step closer to offering real hope to the more than 30,000 Americans who suffer from one of the most lethal of all cancers.
"During the course of this submission, we will continue to engage in regular meetings with the FDA to ensure that the process is thorough and on schedule," added Dr. Rubinfeld. "Assuming there are no unforeseen delays, we anticipate presenting the data from our Phase III Orathecin program at the Annual Meeting of ASCO next May."
Last month, the company was granted a 'fast-track' designation for Orathecin. Fast-track designation 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.
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.