Berlex’ Bonefos “Approvable”
This article was originally published in The Pink Sheet Daily
Executive Summary
Berlex' oral non-amino bisphosphonate Bonefos (clodronate) is "approvable" at FDA for breast cancer bone metastases
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FDA will not approve the breast cancer bone metastases treatment before seeing confirmatory efficacy results from the National Surgical Adjuvant Breast & Bowel Project B-34 study. The drug was deemed "approvable" in January.
Bonefos Approval Contingent On Study Results Expected In 2008
FDA will not approve the breast cancer bone metastases treatment before seeing confirmatory efficacy results from the National Surgical Adjuvant Breast & Bowel Project B-34 study. The drug was deemed "approvable" in January.
Berlex Bonefos Meeting For Breast Cancer Metastases Cancelled
It is the second time an FDA advisory committee meeting for Bonefos has been cancelled. The oncologics committee will still meet Dec. 1 to review Ilex/Enzon’s Marqibo and Ilex’ Clolar.