Results from the pivotal phase III MONALEESA-2 study show LEE011 (ribociclib) plus letrozole significantly extended progression-free survival (PFS), compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (median PFS, 95% CI (19.3 months – not reached) vs 14.7 months (13.0 – 16.5 months); HR=0.556; p=0.00000329.
FDA approved Poherdy (pertuzumab-dpzb) as an interchangeable biosimilar to Perjeta (pertuzumab). This is the first approval of a biosimilar for Perjeta.
