Advanced Magnetics of Cambridge, MA has announced the submission of a New Drug Application with the U.S. Food and Drug Administration for its Combidex magnetic resonance imaging contrast agent.
The NDA covers two indications. The principal indication is for the diagnosis of lymph node disease to assist in directing biopsy and surgery, as well as to aid in the staging of metastatic lymph node involvement for a variety of cancers, including breast and prostate cancer.
In clinical studies of this application, Combidex significantly reduced the number of false diagnoses (both false positive and false negative nodes) compared to unenhanced MRI exams, according to the company.
The second indication is for the detection, diagnosis and characterization of benign versus malignant lesions of the liver and spleen.
The FDA has 60 days to review the application before deciding whether or not to accept the filing. In Europe, Advanced Magnetics' European marketing partner, Guerbet S.A., submitted a Dossier (the European equivalent of an NDA) with the European Medicines Evaluations Agency on December 17, 1999. Guerbet anticipates market launch of Combidex (under the tradename Sinerem(TM)) in early 2001.
According to the company, Combidex is the first contrast agent to be developed that could assist oncologists and radiologists in the non-invasive staging of metastatic cancer in lymph nodes.
Advanced Magnetics is a biopharmaceutical company that develops and commercializes products for diagnosing cancer and other diseases.
By AuntMinnie.com staff writers
December 21, 1999
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