FDA Grants Lasofoxifene Fast Track Designation for ER+/ESR1-Mutant Metastatic Breast Cancer

May 29, 2019 – The FDA has granted a fast track designation to lasofoxifene for use as a treatment of female patients with estrogen receptor (ER)–positive, HER2-negative metastatic breast cancer who harbor ESR1 mutations. The investigational agent is being evaluated in comparison with fulvestrant in the phase II ELAINE trial, which is enrolling up to 100 postmenopausal patients with acquired ESR1-mutant locally advanced or metastatic ER-positive, HER2- … (leggi tutto)