четверг, 22 декабря 2016 г.

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

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