Capromab pendetide was approved by the U.S. Food and Drug Administration (FDA) on October 28, 1996. It was developed and marketed as ProstaScint® by Cytogen (a member of EUSA Pharma).
Capromab pendetide is a murine monoclonal antibody, which is directed against a glycoprotein expressed by prostate epithelium known as Prostate Specific Membrane Antigen (PSMA). It is indicated as a diagnostic imaging agent in newly-diagnosed patients with biopsy-proven prostate cancer.
ProstaScint® is available as a kit for intravenous use, containing 0.5 mg/mL of Capromab pendetide. The recommended dose is 0.5 mg radiolabeled with 5 mCi of Indium In 111 chloride given over 5 minutes.
|Approval Date||Approval Type||Trade Name||Indication||Dosage Form||Strength||Company||Review Classification|
|1996-10-28||Marketing approval||ProstaScint||Prostate cancer||Injection||0.5 mg/mL||EUSA Pharma|
|Expression System||Mammalian Cell|