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ODAC votes against Zarnestra

May 6, 2005 12:56 AM UTC

FDA's Oncologic Drugs Advisory Committee voted unanimously against recommending conventional approval and 7-4 against accelerated approval of Johnson & Johnson subsidiary Tibotec's Zarnestra tipifarnib. JNJ is seeking approval to treat elderly patients with newly diagnosed, poor-risk acute myeloid leukemia (AML). ODAC members said they were not confident that the complete response rate --11% confirmed and 15% investigator-reported -- would translate into a clinically relevant benefit. ...