Onco-Summaries: Daily Oncology Updates at a Glance
04/09/2026
US FDA grants accelerated approval for camizestrant combination as first-line treatment of ESR1-mutated advanced ER+ Breast cancer (Ref)
AstraZeneca announced that the US FDA has granted accelerated approval for Etcamah (camizestrant; next-generation oral SERD and complete ER antagonist) in combination with a CDK4/6 inhibitor for first-line treatment of HR-positive, HER2-negative advanced breast cancer upon detection of ESR1 mutation during aromatase inhibitor (AI) and CDK4/6 inhibitor therapy, based on a US Food and Drug Administration (FDA)-authorised test
The accelerated approval was based on results from the pivotal Phase 3 SERENA-6 trial
Regimen demonstrated a 56% reduction in risk of progression or death compared to standard AI + CDK4/6 therapy; HR: 0.44; p<0.00001
Median PFS: 16.0 months vs 9.2 months
Statistically significant and clinically meaningful PFS2 benefit was observed at a subsequent pre-planned analysis: 25.7 vs 19.1 months
Overall survival (OS) was immature at the time of the interim analysis; continues to mature in favor of the Etcamah combination (HR: 0.87; 95% CI: 0.57–1.30), with the trial ongoing to evaluate OS as a key secondary endpoint
Safety Profile was consistent with known CDK4/6 inhibitor safety with no new concerns identified
Concurrently with this approval, the FDA also approved a companion diagnostic test to detect emerging ESR1 resistance mutations in the circulating tumour DNA (ctDNA) of patients with HR-positive, HER2-negative advanced or metastatic breast cancer
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