US firm, SuperGen, saw 16% wiped off its share price yesterday after revealing that it had withdrawn the US filing for its pancreatic cancer agent, Orathecin (rubitecan), after the US Food and Drug Administration indicated that the current data package would not be sufficient to win approval at this time.
SuperGen’s chairman, president and chief executive, Dr James Manuso, said: “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 company says that the drug’s European filing remains on track, and also says that it is proceeding with the US portion of a Phase III trial of Orathecin and
Eli Lilly’s Gemzar (gemcitabine) as a combination first-line therapy for the treatment of advanced pancreatic cancer.