Cytogen Corp. and its European marketing partner, EuroCetus (abusiness of Chiron Corp.), announced Tuesday that Cytogen'smonoclonal antibody-based cancer imaging agent has beenrecommended for approval for two new use indications inEurope.
The European Community's Committee for ProprietaryMedicinal Products (CPMP) approved the imaging agent,OncoScint CR103, for single-use administration as a diagnosticfor colorectal adenocarcinoma in June 1991. The two newindications extend the prior use to include: determining theextent of malignancy in patients with suspected recurrentovarian cancer; and repeated use of the diagnostic in patientswith suspected recurrent carcinoma, as long as those patientshave not developed a HAMA (human anti-mouse antibody)response to the diagnostic agent.
Individual member countries of the European Community stillmust decide whether to approve the amendments. TheOncoScint product is already being marketed in eight WesternEuropean countries.
Cytogen (NASDAQ:CYTO) of Princeton, N.J., has already filed anamendment in the U.S. for repeat administration of thediagnostic imaging agent. The product was approved asOncoscint CR/OV for marketing (for single-use administrationin patients with colorectal or ovarian cancer) by the FDA inDecember 1992.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.