Cytogen of Princeton, NJ, appeared before the Committee for Proprietary Medicinal Products of the European Community this month with an application to register OncoScint CR103, a colorectal cancer monoclonal antibody imaging agent. The CPMP last week requested the company to provide written confirmation of its oral presentations, said Cheryl Shipley Coyle, Cytogen director of marketing and corporate communications.

EuroCetus, Cytogen's European marketing partner (SCAN 1/17/90), is handling the regulatory process for the U.S. company. All data for the application were obtained through U.S. clinical trials, Coyle said. She could not confirm, however, whether this is the first time a European monoclonal antibody application has been made without supporting European data.

Although the CPMP has yet not handed down a decision, the fact that it did not reject the application out of hand because of the lack of European data is a hopeful sign for U.S. monoclonal antibody developers.

Centocor's Myoscint cardiac agent is the only monoclonal antibody imaging agent to have received CPMP endorsement (SCAN 6/15/89). Myoscint has also received national approvals, which are required before marketing can take place in individual European countries. No monoclonal antibody imaging agents have been approved for market in the U.S.

Cytogen expected a rigorous process for the OncoScint application.

"As this is going to be the first monoclonal agent for cancer, they (the CPMP) are dotting their i's and crossing their t's," Coyle said.