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news.The US Food and Drug Administration (FDA) has approved a new indication expanding the use of AstraZeneca's FASLODEX (fulvestrant) to include use in combination with palbociclib.
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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 after endocrine therapy.
FASLODEX has been approved since 2002 as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.
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 tumor growth.1,2
"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.
The most common adverse reactions (=10%) of any grade reported in PALOMA-3 of FASLODEX plus palbociclib vs FASLODEX plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (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%).1 For more information, please see Important Safety Information for FASLODEX below.
"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.