An FDA panel on Thursday voted 7 to 4 against recommending Johnson & Johnson's Zarnestra (tipifarnib) for accelerated approval as a treatment for acute myeloid leukaemia in patients 65 and older, SmartMoney and other news sources report. The FDA is considering the drug for fast-track approval as a treatment for patients who are newly diagnosed with AML.
Panellists who recommended against approval said it was unclear who would benefit from the drug. A late-stage trial of Zarnestra showed that of about 135 patients, 11 percent had a complete response to the drug, as reported in SmartMoney. Cancer went into remission for an average of 275 days. Overall, 45 percent were alive after six months and 25 percent were alive after one year.
"I don't really know which patients are going to respond," said panellist Dr. Bruce Cheson, as reported in MSNBC.
The drugmaker said it was disappointed with the panel's vote but would await a decision by the agency. The company added that it would continue with a Phase III study of the drug. Results from the trial are expected in 2007, as reported in SmartMoney.
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