Monoclonal Antibody Radionuclide Test Kits

ARCITUMOMAB170

Arcitumomab (CEA-Scan) is a murine monoclonal Fab' fragment of IMMU-4, an MAb generated in murine ascites fluid. Both IMMU-4 and arcitumomab react with carci-noembryonic antigen (CEA), a tumor-associated antigen whose expression is increased in various carcinomas, especially those of the GI tract. The preparation is a protein, murine Ig Fab fragment from IgG1, for chemical labeling with Tc-99m.

Arcitumomab/Tc-99m is for use with standard diagnostic evaluations for detecting the presence, location, and extent of recurrent or metastatic colorectal carcinoma involving the liver, extrahepatic abdomen, and pelvis, with a histologically confirmed diagnosis. IMMU-4 (and the Fab' fragments of arcitumomab) bind to carcinoembryonic antigen (CEA), whose expression is increased in carcinoma. Arcitumomab/Tc-99m is injected, and the radionuclide scan is read 2 to 5 hours later.

NOFETUMOMAB MERPENTAN171

Nofetumomab merpentan (Verluma Kit) is the Fab fragment derived from the murine MAb NR-LU-10. The product is a protein, IgG2b, monoclonal that has been fragmented from NR-LU-10. Nofetumomab possesses only the Fab portion. NR-LU-10 and nofetumomab are directed against a 40-kDa protein antigen that is expressed in various cancers and some normal tissues.

Nofetumomab is indicated for the detection and evaluation of extensive-stage disease in patients with biopsy-confirmed, previously untreated small cell lung cancer by bone scan, CT scan (head, chest, abdomen), or chest x-ray.

Nofetumomab merpentan possesses a linker and a chelator that binds the technetium to the peptide. This is a phenthioate ligand, 2,3,5,6-tetrafluorophenyl-4,5-bis-5-[1-ethoxyethyl]-thioacetoamidopentanoate, hence the name merpentan.

SATUMOMAB PENDETIDE172

Satumomab pendetide (OncoScint, murine) is a kit for In-111. Satumomab is prepared from a murine antibody raised to a membrane-enriched extract of human breast carcinoma hepatic metastasis. It is a protein, IgG1 k antibody, and monoclonal. The MAb recognizes tumor-associated glycoprotein (TAG) 72, a mucinlike molecule with a mass greater than 100,000 Da.

Satumomab is indicated as a diagnostic aid in determining the extent and location of extrahepatic malignant disease in patients with known colorectal and ovarian cancer. This agent is used after standard diagnostic tests are completed and when additional information is needed. The cancer must be recurrent or previously diagnosed by other methods.

Satumomab localizes to TAG 72. The antibody is chemically modified so that it links to radioactive indium-111, which is mixed with the antibody just prior to injection. Imaging techniques will reveal the localization of the satumomab as "hot spots." To link the indium-111 to the satumomab protein, a linker-chelator is used. This is gly-cyl-tyrosyl-(N,e-diethylenetriaminepentaacetic acid)-ly-sine hydrochloride.

IMCIROMAB PENTETATE173

Imciromab pentetate (murine; Myoscint Kit for the preparation of indium-111 imciromab pentetate) is a murine im-munoglobulin fragment raised to the heavy chain of human myosin. The drug is a protein of the IgG2 k class. It is monoclonal, consisting of the Fab-binding fragments only, and it is bound to the linker-chelator diethylenetriamine pen-taacetic acid for labeling with indium-111. Imciromab binds to the heavy chain of human myosin, the intracellular protein found in cardiac and skeletal muscle cells.

Imciromab pentetate is indicated for detecting the presence and location of myocardial injury in patients after a suspected myocardial infarction. In normal myocardium, intracellular proteins such as myosin are isolated from the extravascular space by the cell membrane and are inaccessible to antibody binding. After myocyte injury, the cell membrane loses integrity and becomes permeable to macromolecules, which allows Imciromab-In-111 to enter the cells, where it binds to in-tracellular myosin. The drug localizes in infarcted tissues, where radionuclide scanning can visualize it.

CAPROMAB PENDETIDE174

Capromab (ProstaScint Kit for the preparation of In-111 capromab pendetide, murine) is an MAb (murine IgG1 k) that derives from an initial sensitization with a glycoprotein expressed by prostate epithelium known as prostate surface membrane antigen (PSMA). The MAb recognizes PSMA specifically and thus is specific for prostate adenocarcino-mas. The drug is used in newly diagnosed patients with proven prostate cancer who are at high risk for pelvic lymph metastasis. PSMA has been found in many primary and metastatic prostate cancer lesions. The cytoplasmic domain marker 7E11-C5.3 reacts with more than 95% of adenocar-cinomas evaluated.

To join the indium-111 to the antibody, a linker-chelator is used. This moiety is glycyltyrosyl-(N-ethylenetriamine-pentaacetic acid)-lysine HCl.

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