The FDA approved Eli Lilly's Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) on Friday, September 18, 2026 for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The FDA also approved the Guardant360 CDx assay as the companion diagnostic for detecting ESR1 mutations. The approval rests on the EMBER-3 trial, which enrolled 874 adults; in the 159-patient ESR1-mutated subgroup, median progression-free survival was 11.1 months with the combination versus 5.5 months with imlunestrant alone (hazard ratio 0.53). Objective response rates were 35% and 15%, respectively.
AstraZeneca (NASDAQ: AZN) announced Friday September 4, 2026 that the FDA granted accelerated approval to Etcamah (camizestrant, an oral selective estrogen receptor degrader) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone-receptor-positive HER2-negative locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor plus CDK4/6 inhibitor therapy. FDA also approved the Guardant360 CDx blood-based next-generation sequencing assay as a companion diagnostic to identify ESR1-mutant patients. Approval was based on the Phase 3 SERENA-6 trial that documented a 56% reduction in disease progression or death versus continued standard-of-care aromatase inhibitor plus CDK4/6 inhibitor treatment in the ESR1-mutated subgroup. SERENA-6 was presented at ASCO 2026 and simultaneously published in the New England Journal of Medicine. Etcamah becomes the first oral SERD approved for the switch-at-emergence-of-ESR1 setting, replacing the fulvestrant intramuscular injection historically used post-progression. AstraZeneca is positioning Etcamah alongside Trodelvy plus Datroway as anchors of the expanded breast-cancer franchise.