Faslodex Approved as Combo Tx for Advanced Breast Cancer

The FDA approval is based on data from the Phase 3 MONARCH 2 trial, which met the study's primary endpoint of PFS.

AstraZeneca announced that the Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) for use with abemaciclib, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) in women with disease progression after endocrine therapy. 

The expanded approval was supported by data from the Phase 3 MONARCH 2 trial (n=669) that included women with HR+, HER2- advanced breast cancer. In the study, there was a statistically significant increase in investigator-assessed median progression-free survival (PFS) of 7.1 months (16.4 months vs. 9.3 months) in patients who received Faslodex 500mg + abemaciclib 150mg vs. Faslodex 500mg + placebo (hazard ratio [HR] 0.553, 95% CI:0.449 to 0.681; P<0.0001). 

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Common adverse reactions seen with Faslodex + abemaciclib vs. Faslodex + placebo were diarrhea, neutropenia, fatigue, nausea, infections, abdominal, pain, anemia, leukopenia, decreased appetite, vomiting, and headache.

Faslodex, an estrogen receptor antagonist, was initially approved in 2002 for postmenopausal women with HR+ advanced breast cancer with disease progression following endocrine therapy. Then in 2016, it was approved for use with palbociclib, for the treatment of women with HR+, HER2- advanced or MBC, whose cancer has progressed after endocrine therapy. In August 2017, it was approved for the treatment of HR+, HER2- advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.

For more information call (800) 237-8898 or visit Faslodex.com.