First Approval For Wellcome, Centocor's Panorex

Wellcome of the UK and Centocor of the USA have received approval to market their anticancer monoclonal antibody product Panorex (17-1A), in Germany, as an adjuvant therapy in the treatment of postoperative colorectal cancer. The Paul Ehrlich Institute issued the approval on January 4, just over six months after the application was submitted.

Centocor will manufacture the product for Wellcome, which will distribute it on a worldwide basis. Wellcome says it expects to launch the product in Germany within the next few months.

A Phase III clinical trial of Panorex, which formed the basis of the Product License Application dossier, was published in The Lancet in May 1994 (see also Marketletter May 23). In the study, 189 patients were randomized to receive either an observation regimen or post-operative treatment with 500mg of Panorex by infusion, followed by four 100mg infusions each month for five months. Follow-up continued for five years, whereupon it was found that treatment with the antibody reduced the overall death rate by 30% and decreased the tumor recurrence rate by 27%.