FDA Grants Priority Review to sNDA for Full Approval of Palbociclib in Breast Cancer

21 dicembre 2016 – The FDA has granted a priority review to a supplemental new drug application (sNDA) supporting the conversion of the accelerated approval of palbociclib (Ibrance) to a full approval for use in combination with letrozole as a frontline treatment for postmenopausal women with ER-positive, HER2-negative metastatic breast cancer. The sNDA for the CDK 4/6 inhibitor is based on the phase III PALOMA-2 trial, in which adding palbociclib to letrozole … (leggi tutto)