Berlex Bonefos review
Executive Summary
FDA's Oncologic Drugs Advisory Committee will discuss Berlex' NDA (21-776) for Bonefos (clodronate) as an adjuvant treatment for the reduction of occurrence of bone metastases in Stage II/III breast cancer patients on Dec. 2. Bonefos has an estimated user fee deadline of March 9, 2005. The committee will also review Ilex/Enzon's liposomal vincristine formulation Marqibo NDA (21-600) for relapsed aggressive non-Hodgkin's lymphoma and Ilex' Clolar (clofarabine) NDA (21-673) for pediatric patients (1-21 years) with refractory or relapsed acute leukemias on Dec. 1 (1"The Pink Sheet" Oct. 4, 2004, In Brief). The meeting will be held at the Holiday Inn in Silver Spring, Md. beginning at 8 a.m. on Dec. 1 and 8:30 a.m. on Dec. 2. [Editor's Note: To 2watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...