Business Updates And Product Approval News, In Brief
Executive Summary
FDA approves Tykerb expanded indication: FDA cleared GlaxoSmithKline's Tykerb (lapatinib) Jan. 29 for use in combination with Novartis' Femara (letrozole) to treat hormone-positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated. Though overall survival data is not mature from the trial, women treated with Tykerb plus Femara had nearly double benefit in progression-free survival, 35 weeks versus 13 weeks for Femara alone; that finding was the basis for the approval. The application had been slated for review at the Dec. 16 meeting of the Oncologic Drugs Advisory Committee, but FDA dropped Tykerb from the agenda, with the explanation that it had resolved the issue for which it was seeking discussion