ARTICLE | Regulation

Long Wait Isn't Over for Immunomedics

May 31, 1994 7:00 AM UTC

More than three years after filing its PLA for ImmuRAID-CEA for colorectal cancer imaging, Immunomedics Inc. (IMMU) received a not approvable letter from the FDA. CFO Amy Factor said the Morris Plains, N.J., company has contacted the agency to set a meeting to clarify the issues raised in the letter, but no date has been set. Factor declined to comment on how long a delay might be entailed or on whether more trials may be required until after the company meets with the agency.

The PLA for the antibody fragment linked to technetium-99 was filed in April 1991. IMMU has five other imaging agents in its pipeline, all antibody fragments labeled with technetium-99. Most advanced is LeucoScan (ImmuRAID-MN3) for infectious disease. LeucoScan is finishing Phase III studies and the company plans to file a PLA by the end of the year. IMMU's lung cancer imaging agent, the same product as the colorectal agent, just started Phase III studies. Factor said the FDA letter won't affect those trials...