EU appro for Novartis' Femara as first-line

Swiss pharmaceutical major Novartis on January 26 received approvalunder the European Union's mutual recognition procedure to market Femara (letrozole) in 14 countries as a first-line treatment for postmenopausal women with hormone-dependent advanced breast cancer.

Individual country marketing authorizations should follow within 45 days, according to Novartis, which notes that it also received approval, under a separate national procedure, from the UK's Medicines Control Agency as first-line therapy for this condition, which the US Food and Drug Administration also cleared recently (Marketletter December 18, 2000).

Supporting the EU approval application was a Phase III head-to-head clinical study comparing Femara with the gold-standard therapy, tamoxifen, in over 900 postmenopausal women who had locally-advanced (stage IIIB) or metastatic breast cancer, or recurrence not amenable to treatment with surgery or radiotherapy.