Johnson & Johnson said Thursday that it received a "not approvable letter" from the FDA regarding its application for tipifarnib as a treatment for acute myeloid leukaemia (AML) in elderly patients who cannot undergo standard chemotherapy, as reported in Forbes and other news sources.
The application for the drug was supported by data from a single Phase II trial, as reported in news sources. In May, an FDA advisory committee voted 7 to 4 against the drug, saying that it needed more research, TheStreet reports. The FDA usually requires data from three sets of trials.
The FDA granted the drug priority-review status in June 2004 and also designated it as an orphan drug, as reported in SmartMoney.
The drugmaker said that it remains committed to developing the drug, Zarnestra, and is studying the rejection letter to determine its next steps, TheStreet reports.
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