Cytogen submits U.S. data in Europe

Cytogen of Princeton, NJ, appeared before the Committee for ProprietaryMedicinal Products of the European Community this month with anapplication to register OncoScint CR103, a colorectal cancer monoclonalantibody imaging agent. The CPMP last week requested the companyto provide written confirmation of its oral presentations, saidCheryl Shipley Coyle, Cytogen director of marketing and corporatecommunications.

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

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

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

Cytogen expected a rigorous process for the OncoScint application.

"As this is going to be the first monoclonal agent forcancer, they (the CPMP) are dotting their i's and crossing theirt's," Coyle said.