FDA Committee Advises Against Early Approval for J&J's Zarnestra

May 16, 2005

The FDA's Oncologic Drugs Advisory Committee has recommended against accelerated approval for cancer drug Zarnestra, for which sponsor Johnson & Johnson (J&J) had hoped to obtain approval before completing Phase III clinical trials.

Committee members decided in a 7-4 vote that J&J should be required to submit Phase III data before Zarnestra (tipifarnib) can be approved. Most panelists concurred that currently available data -- a single-arm Phase II study -- doesn't provide a clear enough picture about the drug's benefits. J&J is seeking approval of Zarnestra as a treatment for newly diagnosed elderly patients with acute myeloid leukemia (AML).

J&J has already started enrollment for a Phase III trial comparing Zarnestra to best supportive care in AML patients ages 70 years and older, but the company estimated that data from the trial are at least two years away. J&J said it might be able to submit Phase III results to the FDA by early 2007.