Tipifarnib to be Reviewed for its Indication in Acute Myeloid Leukemia
Apr 6, 2005 - 7:03:00 AM
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.
By FDA advisory committe, [RxPG] 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.
Publication:
The Oncologic Drugs Advisory Committee
On the web:FDA advisory committe
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This meeting will be held May 5, 2005 at the Advisors and Consultants Staff conference room, 5630 Fishers Lane in Rockville, Md. beginning at 8:30 a.m.
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