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Rolling NDA Submitted for Rubitecan, Potential Pancreatic Cancer Treatment
DUBLIN, Calif., Jan. 27 /PRNewswire-FirstCall/ -- SuperGen Inc. announced today that it has completed submission to the FDA of a rolling New Drug Application (NDA) for the investigational anticancer compound Orathecin™ (rubitecan) capsules. Orathecin is an oral chemotherapy agent that has been investigated as a treatment for pancreatic cancer patients who are refractory/resistant to the limited available therapies in this disease. Two other portions of the NDA, the Chemistry/Manufacturing/Controls and the Preclinical portions, were submitted earlier.
The Clinical Module of the NDA, which completed the submission, contains data on more than 1,000 pancreatic cancer patients, with over 600 of them treated with Orathecin and the remainder with control therapies. SuperGen's Phase III clinical program is believed to be the largest clinical development program in pancreatic cancer ever initiated worldwide.
"On the occasion of this important company milestone, I would like to acknowledge our team at SuperGen, whose considerable efforts were instrumental in the completion of this complex NDA process," said Dr. James Manuso, Chairman, President and Chief Executive Officer of SuperGen.
In November 2002, the company was granted a 'fast-track' designation for Orathecin for use in pancreatic cancer patients. "Fast-track" designation means that the FDA agrees to facilitate development and review of the application for new drugs that show promise in a serious or life-threatening condition where there is an unmet medical need. Pancreatic cancer patients who have failed the available therapies present a clear unmet medical need.
According to the Pancreatic Cancer Action Network (PanCAN), pancreatic cancer has the highest fatality rate of all cancers. Approximately 30,700 people will be diagnosed with pancreatic cancer this year in the United States and 30,000 people will die. Pancreatic cancer is the fourth highest cancer killer in the United States amongst both men and women. The 99 percent mortality rate for pancreatic cancer is the highest of any cancer.