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SuperGen withdraws Orathecin EU application

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

SuperGen has withdrawn its European marketing authorization application for its oral pancreatic cancer agent Orathecin (rubitecan), the firm announces Jan. 20. The oral camptothecin's future appears to hinge on an ongoing U.S. Phase II trial looking at Orathecin in combination with gemcitabine in the first-line pancreatic cancer setting. "SuperGen intends to make a decision on future development or the alternative disposition of Orathecin based on a review of the interim results of this trial, expected to occur during the first half of 2006," the firm says. In January 2005, SuperGen withdrew an NDA seeking a monotherapy claim for Orathecin, citing FDA's focus on statistical versus clinical benefit (1Pharmaceutical Approvals Monthly January 2005, p. 39). The firm had expected a more favorable stance from EMEA, but the European agency raised several "major concerns" and said it "considers that the overall risks of the product were higher than the benefits to patients"...

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