FDA accepts Pfizer's marketing application for expanded use of breast ...


The FDA accepts for review Pfizer's supplemental New Drug Application seeking approval for the use of IBRANCE , in combination with letrozole, to treat postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer. The application includes data from the Phase 3 PALOMA-2 study which was conducted in the same patient population as the Phase 2 PALOMA-1 trial, the basis for accelerated approval status granted by the FDA in February 2015.



from Biotech News