FDA approves combo for ESR1-mutated breast cancer
MDSpire News
September 21, 2026
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The FDA approved imlunestrant with abemaciclib for adults with ESR1-mutated advanced breast cancer after prior endocrine therapy.
The Guardant360 CDx assay was authorized as a companion device to detect ESR1 mutations for patient selection.
The EMBER-3 trial involved 874 adults with estrogen receptor-positive, HER2-negative breast cancer previously treated with aromatase inhibitors.
Imlunestrant plus abemaciclib showed statistically significant improvement in progression-free survival compared to imlunestrant alone.
In patients with ESR1 mutations, median progression-free survival was 11.1 months with the combination therapy versus 5.5 months with monotherapy.
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