Immunomedics to present CEA-Scan data

September 27, 1995

Monoclonal antibody imaging agent developer Immunomedics of MorrisPlains, NJ, said this month that the Food and Drug Administrationhas scheduled a date for the company to present data from clinicaltrials for its CEA-Scan colorectal cancer imaging agent.

Monoclonal antibody imaging agent developer Immunomedics of MorrisPlains, NJ, said this month that the Food and Drug Administrationhas scheduled a date for the company to present data from clinicaltrials for its CEA-Scan colorectal cancer imaging agent. The moveis a follow-up to an action last year in which the FDA said CEA-Scan'sproduct license application was not approvable in its form atthe time (SCAN 6/1/94).

The FDA has scheduled the meeting for Oct. 17, at which timethe two parties will discuss the FDA's request for clarificationof the data and analyses Immunomedics provided the agency in responseto the not-approvable letter. The regulatory status of CEA-Scan'sPLA for colorectal cancer imaging is not-yet-approvable, accordingto Immunomedics.

In other Immunomedics news, the company reported progress onseveral other agents it is developing. It said last week thatphase-III clinical trials for its LeukoScan infectious diseaseimaging agent have demonstrated clear diagnostic utility for imagingbone infections. Other trials have supported the use of CEA-Scanin breast cancer imaging.