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FDA expands use for breast cancer drug
FDA has approved expanded indication for the use of fulvestrant (Faslodex, AstraZeneca) in combination with another therapy in the treatment of metastatic breast cancer.
FDA has approved expanded indication for the use of fulvestrant (Faslodex, AstraZeneca) in combination with another therapy in the treatment of metastatic breast cancer.
Faslodex was originally approved in 2002 as monotherapy for the treatment of postmenopausal women with hormone receptor positive (HR+) metastatic breast cancer (MBC) whose cancer has progressed following antiestrogen therapy.
Faslodex is now approved in combination with Pfizer’s palbociclib for the treatment of women with HR+, human epidermal growth factor receptor 2 negative (HER 2-) advanced or MBC whose cancer has progressed after endocrine therapy.
Related: FDA expands Opdivo use for metastatic melanoma
The wholesale acquisition cost for a once monthly injection of Faslodex is around $1,107.
MBC is the most advanced stage of breast cancer (stage four), and occurs when cancerous cells spread beyond the initial tumor site to other parts of the body outside of the breast. Estrogen receptor positive (ER+) breast cancer is the most common subtype of breast cancer. In this subtype, cancer cells, like normal breast cells, may receive signals from estrogen that could promote their growth. Breast cancer may also be classified as progesterone-receptor positive (PR+). Approximately two thirds of breast cancers test positive for hormone receptors.
Faslodex is an antineoplastic agent that directly targets the ER by blocking and degrading the receptor, helping to inhibit tumor growth. Faslodex is administered as an intramuscular injection once monthly and should be used with caution in patients with bleeding disorders or in patients on anticoagulants.
Related: Cotellic approved as part of combo treatment for advanced melanoma
FDA's approval of Faslodex is based on data from the phase 3 trial, PALOMA-3, which studied Faslodex in women with HR+ HER2- advanced or metastatic breast cancer whose disease had progressed after endocrine therapy. The combination of Faslodex 500 mg and palbociclib 125 mg resulted in a 4.9-month progression-free survival (PFS) improvement over Faslodex plus placebo. This improvement was noted in patients irrespective of menopausal status.
Some of the most common adverse reactions associated with the use of Faslodex plus palbociclib in the study included neutropenia, leukopenia, infections, fatigue and nausea.
