US regulators have expanded the scope of AstraZeneca’s breast cancer drug Faslodex to include the drug’s use in combination with Pfizer's Ibrance. 

The decision means that the combination can now be used to treat women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy.

Faslodex (fulvestrant) has been approved since 2002 as a monotherapy for the treatment of postmenopausal women with HR and MBC whose cancer has progressed following antiestrogen therapy.

The new indication “provides another important treatment option for patients,” as the combination showed “a clear increase in progression-free survival in patients” compared to Faslodex and a placebo, noted Dennis Slamon, chief of the Division of Haematology/Oncology and executive vice chair for research for UCLA's Department of Medicine.

Data from the Phase III PALOMA-3 trial showed that a combination of Faslodex and Ibrance (palbociclib) resulted in a 4.9 month progression free survival improvement over Faslodex and placebo, in women with HR+ HER2- advanced or MBC whose disease had progressed after endocrine therapy.