Zeneca Files 1st Dossier For Tomudex

Zeneca Pharmaceuticals has filed its first Marketing Approval Application for its new anticancer agent Tomudex (formerly ZD 1694) with the UK Medicines Control Agency. If approved, this will be the first new cytotoxic agent to be registered for the treatment of colorectal cancer in the UK in over 30 years.

The UK submission is the first of several to be made across Europe in the coming months, said the company. Meantime, a large Phase III trial is ongoing in the USA, but Zeneca declined to comment on the possible date of a filing. The Phase III data on which the application is based have not been released, said a spokesman, but would be made available at two upcoming cancer meetings in the summer, namely the British Oncology Association meeting (July 9-11) and the International Congress on Chemotherapy (July 17-21).

Phase II data on the drug were presented last year at the European Society of Medical Oncology meeting in Lisbon, Portugal (Marketletter November 28). A total of 177 patients with advanced colorectal cancer were enrolled into the study and received Tomudex 3mg/m2 intravenously every three weeks. Of the 169 assessable patients, four were complete responders, 41 were partial responders, 86 had stable disease and 38 were progressive, indicating an overall response rate of 26%.