ARTICLE | Regulation

No dice for Pixuvri

FDA cancer panel cites trial flaws to reject Pixuvri from Cell Therapeutics

March 29, 2010 7:00 AM UTC

Although Cell Therapeutics Inc. failed to completely enroll its single Phase III study of Pixuvri pixantrone, it bet the results provided sufficient evidence to support accelerated FDA approval of the compound for use to treat aggressive non-Hodgkin's lymphoma in patients with relapsed/refractory disease.

The gamble did not pay off at last week's review by FDA's Oncologic Drugs Advisory Committee, which unanimously concluded the company had failed to provide adequate evidence to support approval, even if the results did suggest that Pixuvri is an active agent...