SuperGen Will Pursue Orathecin As Combo Therapy Following NDA Withdrawal
This article was originally published in Pharmaceutical Approvals Monthly
SuperGen may develop Orathecin as combo therapy following NDA withdrawal. Firm withdrew application in advance of anticipated negative action from FDA. SuperGen is moving ahead with a combination trial with gemcitabine
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SuperGen is pulling the plug on plans for a randomized Phase III trial of its Orathecin combination therapy in first-line pancreatic cancer after a Phase II study fell short of a pre-specified threshold for median survival
SuperGen has withdrawn its European marketing authorization application for its oral pancreatic cancer agent Orathecin (rubitecan), the firm announces Jan. 20.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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