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A new indication for fulvestrant has been approved by the FDA, expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer in women with disease progression after endocrine therapy.

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The FDA approval is based on data from the phase III MONARCH 2 trial, which met the study's primary endpoint of progression-free survival (PFS). The trial included 669 women with HR+, HER2- advanced breast cancer. The results showed a statistically significant increase in investigator-assessed median PFS of 7.1 months (16.4 months vs. 9.3 months) in patients who received fulvestrant 500 mg and abemaciclib 150 mg over fulvestrant and placebo (HR: 0.553; 95% CI: 0.449-0.681; p<0.0001).


This expanded indication is the second FDA approval for fulvestrant in combination with a CDK4/6 inhibitor. The treatment has been licensed in the U.S. since 2016 for use with the CDK4/6 inhibitor, palbociclib, for the treatment of women with HR+, HER2-negative metastatic breast cancer whose cancer has progressed after endocrine therapy.