Tipifarnib to be Reviewed for its Indication in Acute Myeloid Leukemia
Apr 6, 2005 - 7:02:38 AM
The Oncologic Drugs Advisory Committee will review Johnson & Johnsons Zarnestra (tipifarnib) May 5.
J&J is seeking an indication for treatment of patients 65 years and older with newly diagnosed acute myeloid leukemia.
The firm completed submission for the farnesyl transferase inhibitor Dec. 29 under the Continuous Marketing Application Pilot 1 program, setting a six-month review clock.
The NDA is based on Phase II studies using non-survival endpoints. A Phase III trial to fully demonstrate the clinical benefit of tipifarnib was initiated in October 2004.
J&Js Tibotec subsidiary is handling Zarnestras development. Other areas of potential utility include RAS-dependent tumors, for which Phase III studies are underway.
J&J is focusing on RAS-dependent tumors that are not colorectal or pancreatic, since earlier trials showed no benefit over standard of care in either cancer.
Zarnestra is also in development for treatment of a range of myeloid leukemia stages.
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