CIBA-GEIGY FEMARA ADVANCED BREAST CANCER APPROVAL RECOMMENDATION BASED ON RESPONSE RATE DATA; CMTE. SPLITS OVER REQUIRING TAMOXIFEN WASHOUT FOR TRIALS
Executive Summary
Ciba-Geigy's Femara (letrozole) for advanced breast cancer showed a trend towards superiority over a current therapy: at the 2.5 mg strength, Femara yielded 24% complete plus partial tumor response rate compared with 16% for Bristol-Myers Squibb's Megace (megestrol acetate) in a randomized, double-blind Phase III pivotal trial presented to FDA's Oncologic Drugs Advisory Committee Dec. 16.