CombidexTreatment for Body Imaging
Oncologic Drugs Advisory Committee Recommends Against Approval of a Broad Indication For Combidex
CAMBRIDGE, Mass. and PRINCETON, N.J., March 03, 2005 -- Advanced Magnetics, Inc. and Cytogen Corporation announced today that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 15 to 4 to not recommend approval of the proposed indication for Combidex, Advanced Magnetics' investigational functional molecular imaging agent.
In making its recommendation, the committee cited insufficient clinical data to support a broad indication for use of Combidex to differentiate metastatic from non-metastatic lymph nodes across all cancer types.
A decision by the FDA on Combidex is expected by the FDA-designated user fee goal date of March 30, 2005.
"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, Chairman, President and Chief Executive Officer of Advanced Magnetics.
About the ODAC
The ODAC is a committee formed by the FDA of external experts to provide the FDA with independent opinions and recommendations in the evaluation of marketed and investigational drugs for use in the treatment of cancer. The ODAC is comprised of a core of voting members from the fields of general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics and other related professions, as well as a consumer and patient representatives.
About Advanced Magnetics
Advanced Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products. As a leader in its field, Advanced Magnetics is dedicated to the development and commercialization of its proprietary nanoparticle technology for use in therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cardiovascular disease and cancer.
About Cytogen Corporation
Founded in 1980, Cytogen Corporation of Princeton, NJ is a product-driven biopharmaceutical company that develops and commercializes innovative molecules that can be used to build leading franchises across multiple markets. Cytogen's marketed products include Quadramet (samarium Sm-153 lexidronam injection) and Prostascint (capromab pendetide) kit for the preparation of Indium In-111 capromab pendetide in the United States. Cytogen also has exclusive United States marketing rights to Combidex (ferumoxtran-10) for all applications, and the exclusive right to market and sell ferumoxytol (previously Code 7228) for oncology applications in the United States. Combidex, an investigational functional molecular imaging agent consisting of iron oxide nanoparticles, is currently being developed for use in conjunction with magnetic resonance imaging to aid in the differentiation of cancerous and non-cancerous lymph nodes, and is under review by the U.S. Food and Drug Administration. Cytogen's development pipeline consists of therapeutics targeting prostate-specific membrane antigen (PSMA), a protein highly expressed on the surface of prostate cancer cells and the neovasculature of solid tumors.
Posted: March 2005
- Advanced Magnetics, Inc. Receives Approvable Letter From FDA For Combidex - March 24, 2005
- Advanced Magnetics' Combidex to be Reviewed by FDA Oncologic Drugs Advisory Committee - February 1, 2005