SuperGen submits second module of Orathecin's "rolling" NDA as oral treatment for pancreatic cancer
SuperGen submits second module of Orathecin's "rolling" NDA as oral treatment for pancreatic cancer
DUBLIN, CA., Feb. 7, 2003 -- SuperGen announced that it has submitted to the FDA the second of three data modules of the New Drug Application (NDA) for its anticancer compound Orathecin, an oral chemotherapy compound for the treatment of pancreatic cancer patients who are refractory (resistant) to available therapies.
The submission is taking place on a 'rolling' basis with the first module, which contained the chemistry, manufacturing and controls (CMC) section, having been submitted on December 30, 2002.
The second module of the NDA contains the pre-clinical information on Orathecin and consists of 18 volumes and over 4,000 pages of data and analysis.
"We have analyzed and submitted the pre-clinical information quickly and without any unexpected complications," said Dr. Audrey Jakubowski, Ph.D., vice president of regulatory affairs at SuperGen. "We are now turning our attention to the largest module, which represents the massive amounts of data generated from the human studies of Orathecin. In total, more than 2,700 people participated in clinical studies over the past four years."
In November 2002, 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.
The NDA submission will contain data on over 2,700 patients treated under Orathecin study protocols and will be based on portions of 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.
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 percent.
Source: SuperGen www.supergen.com
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