SuperGen, Inc. has received notification from the US FDA that the Agency extended the Pharmaceutical Drug User Fee Act (PDUFA) date for completing its review of the Orathecin (rubitecan) capsules New Drug Application (NDA) to February 26, 2005. Orathecin is SuperGen's investigational drug for the treatment of pancreatic cancer patients who have failed at least one prior chemotherapy regimen, the company said here.
SuperGen submitted additional data from the Company's trial of Orathecin for use as a first-line pancreatic cancer treatment that had been requested by the FDA. The Company also included several new sets of data analysis to further evaluate Orathecin in second and third line patients. Submission of this additional data was classified as a major amendment by the FDA, which allowed the Agency to extend its review by three months.
The first-line phase III pancreatic cancer study enrolled 996 patients who were randomized to receive either Orathecin or gemcitabine. While the trial failed to reach its endpoint of improving survival over gemcitabine, the chemo-naive pancreatic cancer patients that were the subjects of this study fall outside of the proposed use of Orathecin as a second and/or third line therapy in the current NDA SuperGen submitted on January 27, 2004. The treatment of chemo-naive pancreatic cancer patients with Orathecin will be further explored in a proposed, post-marketing, confirmatory study of gemcitabine with or without Orathecin. The completed single agent, chemo- naive study, along with other completed Orathecin trial data, will be presented in a future scientific forum, the company said in the release.
"The additional clinical data submitted to the FDA provides additional support for the Orathecin NDA," stated Dr. James Manuso, Chairman, President and Chief Executive Officer of SuperGen. "We wanted the Agency to have access to the most complete body of clinical data in order to clearly understand the utility of Orathecin," added Dr Manuso.
Orathecin (rubitecan) Capsules, an orally active camptothecin, is a topoisomerase I inhibitor that was developed for the treatment of pancreatic cancer.