First Approval Of Ciba's Femara In France

Ciba has been granted its first regulatory approval, in France, for its aromatase inhibitor Femara (letrozole). The product is indicated for the second-line treatment of advanced breast cancer in postmenopausal women who have already received standard therapy with antiestrogens, such as Zeneca's Nolvadex (tamoxifen).

Ciba notes that the French regulatory authorities approved letrozole in a relatively short time, and that this reflects "both the therapeutic importance of this new treatment for the patient and the quality of the submission." The company expects other European approvals shortly and plans the first launch of the product in the last quarter of 1996. Approval and launch in the USA is expected next year, while a Japanese introduction will follow somewhat later.

Data from a 551-patient study of letrozole were presented in May at the American Society of Clinical Oncology meeting held in Philadelphia. This study enrolled postmenopausal women who had already shown disease progression despite earlier treatment with antiestrogen drugs, and compared letrozole with another agent which is widely-used for second- and third-line breast cancer treatment, Bristol-Myers Squibb's progestogen Megace (megestrol acetate).