FDA Grants Full Approval to Frontline Palbociclib in Breast Cancer

March 31, 2017 – The FDA has granted a full approval to palbociclib for use in combination with letrozole as a frontline treatment for postmenopausal women with ER-positive, HER2-negative metastatic breast cancer. The full approval of the CDK 4/6 inhibitor is based on the phase III PALOMA-2 trial, in which adding palbociclib to letrozole reduced the risk of disease progression by 42% compared with letrozole alone. The median progression-free survival (PFS) was improved by … (leggi tutto)