Advanced Magnetics' Combidex Gets Thumbs Down From FDA Panel

An FDA advisory panel recently agreed not to recommend approval for Advanced Magnetics' Combidex, an investigational molecular imaging agent.

The agency's Oncologic Drugs Advisory Committee voted 15-4 against approving the imaging agent, citing insufficient clinical data. The panel agreed there is not enough data to support a board indication for use of Combidex (ferumoxtran-10) to differentiate metastatic from nonmetastatic lymph nodes across all cancer types.

"We understand the advisory committee's position relative to a broad label for Combidex and look forward to meeting with the FDA to determine appropriate next steps. We remain committed to the ongoing development of Combidex," said Jerome Goldstein, Advanced Magnetics' chairman, president and CEO.

The FDA is expected to make a decision on Advanced Magnetics' new drug application by the user fee goal date of March 30.