The Food and Drug Administration has expanded the indication for fulvestrant to include use in combination with palbociclib for the treatment of women with hormone receptor–positive (HR+), human epidermal growth factor receptor–2 negative (HER2–) advanced or metastatic breast cancer in women whose cancer has progressed after endocrine therapy.
The FDA first approved fulvestrant in 2002 as a monotherapy for the treatment of postmenopausal women with HR+ metastatic breast cancer that had progressed following endocrine therapy.
Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License
Expanded approval is based on data from the Phase III PALOMA-3 trial that found a 4.9 month improvement in progression-free survival with the combination of fulvestrant 500 mg and palbociclib 125 mg, compared with fulvestrant and placebo, in women with HR+ HER2– advanced breast cancer whose disease had progressed after endocrine therapy. Improvement in progression-free survival was seen irrespective of menopausal status, according to a press release from AstraZeneca, makers of fulvestrant.
The most common adverse reactions of any grade reported in PALOMA-3 of the combination vs. fulvestrant plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%), according to the press release.
Fulvestrant is marketed as Faslodex. The new label with prescribing information can be found on the FDA website.