FDA approves new indication for Faslodex (fulvestrant)

Approval expands use and offers additional option for women with HR+, HER2- metastatic breast cancer.

Estrogen receptor (ER) positive breast cancer is the most common subtype of breast cancer and one of the key drivers of disease progression for this subtype is through the ER. Laboratory studies show that Faslodex directly targets the 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 Hematology/Oncology and Executive Vice Chair for Research for UCLA's Department of Medicine.

The FDA approval of this new indication for Faslodex 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 Faslodex 500 mg and palbociclib 125 mg resulted in a 4.9 month PFS improvement over Faslodex 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.

“We believe that advances in cancer treatment will come, in part, from our research building upon existing treatments. This new indication adds to the existing body of evidence supporting Faslodex-based therapy for certain metastatic breast cancer patients in an area where there is still a high unmet medical need,” said Andrew Coop, Vice President, US Medical Affairs, Oncology at AstraZeneca.