AstraZeneca says CHMP adopts positive opinion for Faslodex to expand use
AstraZeneca announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending a new indication for Faslodex that will expand its use to include combination therapy with palbociclib. The combination use is for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. The CHMP opinion is based on data from the Phase III PALOMA-3 trial. The combination of fulvestrant 500 mg and palbociclib 125 mg resulted in a 4.9 month progression-free survival improvement over fulvestrant and placebo in women with HR+, HER2- advanced breast cancer whose disease had progressed after endocrine therapy. Improvement in PFS was seen regardless of menopausal status.2 The most-commonly reported adverse events in fulvestrant plus palbociclib compared to fulvestrant plus placebo were neutropenia, leukopenia and infections.