FDA panel recommends ProstaScint MoAb

July 31, 1996

A Food and Drug Administration advisory committee last week votedunanimously to recommend that the agency approve Cytogen's productlicense application for ProstaScint, a monoclonal antibody-basedimaging agent for detecting prostate cancer. The FDA's

A Food and Drug Administration advisory committee last week votedunanimously to recommend that the agency approve Cytogen's productlicense application for ProstaScint, a monoclonal antibody-basedimaging agent for detecting prostate cancer. The FDA's MedicalImaging Drug Advisory Committee recommended approval for usingProstaScint in patients with prostate cancer in whom there isa high clinical suspicion of occult metastatic disease. The paneladvised that the information provided by ProstaScint be used withother diagnostic information.

Cytogen, of Princeton, NJ, is hoping that ProstaScint willexperience greater commercial success than OncoScint CR/OV, amonoclonal antibody-based agent for detecting colorectal and ovariancancer. OncoScint was launched in 1993 but has experienced slowsales since then. Cytogen believes the market potential for ProstaScintis larger than that of OncoScint: The American Cancer Societyestimates that there will be 317,000 new cases of prostate cancerin the U.S. in 1996, and 41,000 deaths from the disease.

Cytogen is looking for a marketing partner for ProstaScint,and is particularly interested in a company with experience inurology, as urologists are the physicians who will order ProstaScintscans.