Indium In-111 satumomab pendetide

Summary

Indium In-111 satumomab pendetide (OncoScint) was an FDA-approved radioimmunoscintigraphy agent used to detect extrahepatic colorectal and ovarian carcinoma. It consists of a murine monoclonal antibody targeting TAG-72, chelated with pendetide and radiolabeled with Indium-111 for nuclear imaging. It was withdrawn from the US market in the late 1990s due to commercial reasons and the advent of superior imaging technologies.

Mechanism of Action

Satumomab pendetide is a murine monoclonal antibody (B72.3) conjugated to the chelating agent pendetide (GYK-DTPA), which binds to TAG-72 (tumor-associated glycoprotein 72) expressed on many adenocarcinomas. Labeled with Indium-111, it enables gamma scintigraphy-based immunoscintigraphy to detect and localize colorectal and ovarian cancer lesions.

Routes of Administration

Goals & Uses

• Staging and restaging of adenocarcinomasOncology DiagnosticsLow
• Detection of ovarian carcinomaDiagnostic ImagingModerate
• Detection of extrahepatic colorectal carcinomaDiagnostic ImagingModerate

Contraindications

• Hypersensitivity to murine proteins or prior murine antibody exposureAllergy / ImmunologicHigh
• PregnancyPopulationHighPotential fetal risk or insufficient safety data
• BreastfeedingPopulationHighPotential transfer into breast milk or insufficient safety data

Adverse Effects

• Radiation exposureRadiologicalCommon
• Human anti-mouse antibody (HAMA) formationImmunologicCommon
• Hypersensitivity / allergic reactionsImmunologicUncommon
• Fever and chillsConstitutionalUncommon
• NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit

Drug Interactions

• Other murine antibody-based agentsHigh
• ImmunosuppressantsLowPotential interaction with immune pathways or infection risk

Population Constraints

• Renal impairmentOrgan ImpairmentRelative
• Pediatric patientsAgeRelative
• Patients with prior murine antibody therapyImmunologic HistoryRelative

Regulatory Status

• European UnionUnknownNot known to have received formal EU-wide approval; was available in some European countries under national authorizations but is no longer marketed.
• United StatesWithdrawnApproved: Immunoscintigraphy for detection of extrahepatic malignant disease in patients with known colorectal or ovarian cancerFDA-approved in December 1992; voluntarily withdrawn from the market by Cytogen Corporation in the late 1990s for commercial reasons, not due to safety or efficacy findings.

Approved by the FDA in 1992 for immunoscintigraphy of colorectal and ovarian cancer. Subsequently withdrawn from the US market by the manufacturer (Cytogen Corporation) for commercial reasons, not safety concerns. No longer marketed in the US or EU.

Evidence & Sources

No sources recorded yet.