AstraZeneca’s Faslodex approved for new indication in the US

Posted: 8 March 2016 | | No comments yet

The approval expands the use of Faslodex and offers additional options for US women with HR+, HER2- metastatic breast cancer…

The US Food and Drug Administration (FDA) has approved a new indication for AstraZeneca’s Faslodex (fulvestrant), expanding its use with Ibrance (palbociclib) in breast cancer.


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 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+ metastatic breast cancer 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 new Faslodex indication provides another important treatment option for patients, as described in the study, who progressed on or early after prior endocrine therapy. The data supporting combination therapy with Faslodex plus palbociclib showed a clear increase in progression-free survival in patients in the combination arm, as compared to Faslodex and placebo,” said Dr Dennis Slamon, Professor of Medicine, Chief of the Division of Haematology/Oncology and Executive Vice Chair for Research for UCLA’s Department of Medicine.

Approval of the new indication is based on the PALOMA-3 trial

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 metastatic breast cancer whose disease had progressed after endocrine therapy. Improvement in PFS was seen irrespective of menopausal status.

Commenting on the announcement, Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca, said: “This new indication in the US is encouraging news for metastatic breast cancer patients. As a company we are committed to optimising the current standard of care in breast cancer. To achieve this, we are exploring combinations across different scientific platforms through ongoing research and evaluation.”

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