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FDA approves fulvestrant in combination with palbociclib

That the US Food and Drug Administration (FDA) has approved a new indication in the US, expanding the use of fulvestrant to include use in combination with palbociclib.

The combination use is for the treatment of women with hormone receptor-positive (HR ), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed following endocrine therapy.

Fulvestrant has been approved in the US since 2002 and in Europe since 2004 as a monotherapy for the treatment of postmenopausal women with HR MBC whose cancer has progressed following antioestrogen therapy.

The oestrogen hormone receptor positive (ER ) form of breast cancer is the most common subtype, and is one of the key drivers of disease progression.

Preclinical studies show that fulvestrant directly targets the oestrogen receptor (ER) by blocking and degrading the ER, helping to inhibit tumour growth.

The FDA approval of this new indication in the US for fulvestrant is based on data from the Phase III PALOMA-3 trial, which met the study’s primary endpoint of progression-free survival (PFS). 

The combination of fulvestrant 500 mg and palbociclib 125 mg resulted in a 4.9 month PFS improvement over fulvestrant and placebo, in women with HR HER2- advanced or MBC whose disease had progressed after endocrine therapy.

Improvement in PFS was seen irrespective of menopausal status.

Read about the new research, published in The Lancet Oncology, that shows that even women with specific genetic changes conveying resistance to hormone therapy can benefit from the new drug combination.

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