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news.Shares in California-based SuperGen have plummeted over 13% after it withdrew the new dug application for investigational pancreatic cancer drug Orathecin, based on feedback indicating that current data for the drug would not be sufficient to gain approval.
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Orathecin (rubitecan) capsules is SuperGen’s investigational drug for the treatment of pancreatic cancer patients who have failed at least one prior chemotherapy regimen. SuperGen’s decision to withdraw the filing was based on discussions with both the FDA and consultants helping the company in talks with the FDA regarding the Orathecin new drug application (NDA).
SuperGen originally submitted the NDA for Orathecin in January 2004, with a target prescription drug user fee act (PDUFA) date of November 26, 2004.
At the request of the FDA, the company recently submitted additional clinical data from a trial of Orathecin as a first-line treatment for pancreatic cancer, as well as new analyses of data from the pivotal study in second and third line patients. The FDA classified these data as a major amendment, which triggered an extension of the review period by 90 days. The revised target PDUFA date was February 26, 2005.
Dr James Manuso, chairman, president and CEO of SuperGen, stated, “Based on the feedback we received, we decided it was best for the long-term development of Orathecin to withdraw the application. After we review the FDA’s complete findings, we will determine the most appropriate course of action for Orathecin in the US.”
The European filing for Orathecin remains on track and the company is continuing to advance its planned phase III trial of Orathecin and gemcitabine as a combination first-line therapy for advanced pancreatic cancer in the US.