New FDA approval expands use of AstraZeneca's Faslodex for women with HR+, HER2- metastatic breast cancer

Mar 7 2016

APPROVAL EXPANDS USE AND OFFERS ADDITIONAL OPTION FOR US WOMEN WITH HR+, HER2- METASTATIC BREAST CANCER

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication in the US, expanding the use of Faslodex® (fulvestrant) to include use in combination with Ibrance^® (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 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.

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.

“This new indication in the US is encouraging news for metastatic breast cancer patients,” said Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca. “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.”

The most common adverse reactions (>10%) of any grade reported in PALOMA-3 of fulvestrant plus palbociclib vs fulvestrant plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anaemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhoea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19%vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).