FDA approves CEA-Scan, endinglong wait for Immunomedics

Mallinckrodt readies promotional campaign

After more than a decade of development and clinical tests, anda brutally protracted review process, Immunomedics is just weeksaway from commercializing CEA-Scan, a monoclonal antibody-basedagent designed for the detection of colorectal cancer. On June28 the Food and Drug Administration approved CEA-Scan for salein the U.S., setting the stage for Immunomedics' partner, MallinckrodtMedical, to begin marketing the product domestically (SCAN 4/10/96and 2/28/96).

CEA-Scan's launch date depends on FDA review of Mallinckrodt'spromotional materials, but the company hopes to begin sales inSeptember, according to Randy McBeath, senior oncology marketingmanager for St. Louis-based Mallinckrodt.

Mallinckrodt will launch the product with educational seminarsin 15 to 20 major U.S. cities. On the list of invitees will beevery physician involved in managing colorectal patients, fromnuclear medicine practitioners to colorectal surgeons and medicaloncologists. Mallinckrodt also has rights to the product in Europe,where CEA-Scan is approaching regulatory approval.

Mallinckrodt hopes to avoid the problems that Cytogen ran intowith its OncoScint product, the first monoclonal antibody to beapproved by the FDA (SCAN 1/27/93). Some analysts believe costwas one problem, which was due in part to the use of indium asa radioisotope. The technetium radioisotope used in CEA-Scan isless expensive, giving Immunomedics more flexibility. The finalprice of CEA-Scan has not been set by Immunomedics, but it couldbe as high as $700 per scan. McBeath does not believe, however,that the cost of CEA-Scan will be a deterrent to its use, givenits clinical utility.

Two years ago, Mallinckrodt began marketing Octreoscan, a somatostatin-analogradiopharmaceutical using an indium isotope. The agent is doingwell, but the indications for the product are not as extensiveas colorectal cancer, McBeath said.