Cytogen's ProstaScint wins FDA nod

November 6, 1996

The Food and Drug Administration has granted Cytogen of Princeton,NJ, a license to market its ProstaScint monoclonal antibody agentfor prostate cancer imaging. Cytogen plans to have ProstaScinton the market by early next year. ProstaScint is licensed

The Food and Drug Administration has granted Cytogen of Princeton,NJ, a license to market its ProstaScint monoclonal antibody agentfor prostate cancer imaging. Cytogen plans to have ProstaScinton the market by early next year.

ProstaScint is licensed for two indications: to image newlydiagnosed patients whose biopsy-proven prostate cancer is at highrisk of metastasizing to pelvic lymph nodes, and for post-prostatectomypatients in whom there is a suspicion of cancer recurrence.

Cytogen has licensed ProstaScint rights for the urologicalmarket to C.R. Bard's urologic division, while Cytogen will retainrights to the medical imaging market (SCAN 8/28/96).

Cytogen is hoping that ProstaScint will prove to be more successfulthan its OncoScint CR/OV product for imaging colorectal and ovariancancer. The company plans to support ProstaScint through its Partnersin Excellence program, which is designed to help ensure that nuclearmedicine physicians are reading monoclonal antibody scans correctly(SCAN 9/25/96).