DUBLIN, CA (March 29, 2004) – SuperGen Inc., based here, said Friday that the Food & Drug Administration (FDA) has officially accepted the Orathecin(TM) (rubitecan) capsules’ New Drug Application (NDA) for filing.
Orathecin, an investigational anticancer compound, is an oral chemotherapy agent that has been investigated as a treatment for pancreatic cancer patients who have failed at least one prior chemotherapy.
SuperGen said that November 26 is the target date for the completion of the FDA’s review and resulting action letter for the filed NDA. The filing contained data on more than 1,000 pancreatic cancer patients who failed at least one prior chemotherapy, the company said. Of that group, more than 600 patients received Orathecin and the remainder were given control therapies.
According to the American Cancer Society’s “Cancer Facts and Figures 2004,” nearly 32,000 people will be diagnosed with pancreatic cancer this year in the United States and more than 31,000 people will die. Pancreatic cancer is the fourth highest cancer killer in the U.S. among both men and women. The 99-percent mortality rate for pancreatic cancer is the highest of any cancer, SuperGen said.