FDA Approves New Indication for Breast Cancer Treatment

The FDA has approved the use of Faslodex (fulvestrant, AstraZeneca) in combination with palbociclib for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2- advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy. Fulvestrant was previously approved as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.

Approval was based off data from the Phase III PALOMA-3 trial, which had an endpoint of progression-free survival (PFS). Fulvestrant 500 mg combined with palbociclib 125 mg resulted in a 4.9 month PFS improvement over fulvestrant and placebo in the study population. According to the study, improvement was seen irrespective of menopausal status.

Common adverse reactions for fulvestrant plus palbociclib versus 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%).

Fulvestrant is contradicted in patients with known hypersensitivity to the drug or to any of its components. Hypersensitivity reactions, including urticaria and angioedema have been reported in association with fulvestrant.

For full prescribing information for fulvestrant, click here.