FDA releases Zarnestra documents

Documents released Wednesday suggest FDA's review of Johnson & Johnson subsidiary Tibotec's Zarnestra tipifarnib for elderly patients with newly diagnosed, poor-risk acute myeloid leukemia (AML) did not raise any major barriers to approval. The Oncologic Drugs Advisory Committee is slated to discuss JNJ's application for accelerated approval of Zarnestra on Thursday.

JNJ's claim of a favorable risk-benefit ratio is largely based on a positive safety profile compared with alternative therapies. The 3% treatment-related death rate in the Zarnestra pivotal Phase II open-label trial contrasts with the 25% treatment-related mortality in elderly patients associated with standard AML therapy, which includes cytarabine and daunorubicin. Zarnestra caused one or more serious adverse events in 43% of patients, and drug-related adverse events caused 10% of patients to terminate treatment. According to FDA's analysis, 11% of patients achieved the primary endpoint, a confirmed complete response (CR). Median duration of CR, the secondary endpoint, was 275 days. ...