You are here

New Drug Application for Rubitecan Accepted by FDA

DUBLIN, Calif., March. 26 /PRNewswire-FirstCall/ -- SuperGen Inc. (NASDAQ: SUPG) announced today that the Food and 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.

The FDA indicated that the user fee goal date for the Orathecin NDA is November 26, 2004. This date 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. Of this population, more than 600 patients received Orathecin and the remainder were given control therapies. SuperGen's Phase III clinical program is believed to be the largest clinical development program in pancreatic cancer ever initiated worldwide.

"Our clinical and regulatory teams worked tirelessly to submit a through and complete NDA and we are gratified that it has been accepted by the FDA," said Dr. James Manuso, Chairman, President and Chief Executive Officer of SuperGen. "Although Orathecin is not a cure, we adamantly believe that it can be of benefit to some patients with pancreatic cancer. We are committed to working with the FDA to bringing this drug to market so that it can help the very patients who need it most."

According to the Pancreatic Cancer Action Network (PanCAN), pancreatic cancer has the highest fatality rate of all cancers. According to American Cancer Society Cancer Facts and Figures 2004, 31,860 people will be diagnosed with pancreatic cancer this year in the United States and 31,270 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.

Source: SuperGen Inc.

More Headlines

First and Only Treatment Reduces Depressive Symptoms Within Days
Bone Marrow Cleared of Leukemia in Almost 60% of Patients
Combination of Two Drugs Could Reduce Tumor Growth
Atezolizumab in Combination with Chemotherapy is the Only First-line Cancer Immunotherapy for ES-SCLC
Pre-clinical Trials Showed Drug Inhibits Fibroblast Activity and Collagen Deposition
PARG Inhibitor Exploits Weakness, Kills Cells
Inexpensive, Wearable Therapy Increases Arm Mobility, Reduces Stiffness
National Statistics Report Factors In Race, Ethnicity for the First Time