Berlex Bonefos meeting cancelled
Executive Summary
FDA has cancelled the Dec. 2 meeting of FDA's Oncologic Drugs Advisory Committee that was to look at Berlex' Bonefos for breast cancer bone metastases. It is the second time an advisory committee has been cancelled for Bonefos; in December 2001 an advisory committee meeting was cancelled to allow then-NDA holder Anthra Pharmaceuticals more time to respond to issues raised by FDA. The committee will still review Ilex/Enzon' liposomal vincristine formulation Marqibo and Ilex' Clolar (clofarabine) on Dec. 1 (1"The Pink Sheet" Oct. 11, 2004, In Brief). [Editor's Note: To 2watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...
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Berlex Bonefos review
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.]...
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