Regulatory: AstraZeneca, Praecis

AstraZeneca has received final European marketing approval for its new breast cancer drug Faslodex, following a recommendation from a European Union expert committee in November.

Faslodex is indicated for the treatment of advanced breast cancer in post-menopausal women whose cancer has progressed on previous anti-oestrogen treatments such as tamoxifen.

AstraZeneca, Europe's second biggest drugmaker, said it was the first new type of treatment for hormone receptor positive advanced breast cancer to be approved in the European Union since 1995. It expects first launches of Faslodex in Europe in the second quarter of 2004.

The drug has been on sale since May 2002 in the United States, where sales reached US$77 million in 2003.

Praecis

The US Food and Drug Administration called a halt to a Phase I clinical trial of Massachusetts-based Praecis Pharmaceuticals' PPI-2458 drug in non-Hodgkin's lymphoma until certain questions have been answered.

"We remain committed to the development of PPI-2458 for non-Hodgkin's lymphoma, as well as additional evaluation of its activity in other cancers," said Praecis' chief medical officer, Marc Garnick.