FDA grants accelerated approval to Etcamah combination for ESR1-mutated advanced breast cancer

The FDA has granted accelerated approval to Etcamah in combination with a CDK4/6 inhibitor for adults with ESR1-mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer.

The approval applies to patients whose ESR1 mutation is detected during first-line endocrine-based therapy and introduces a new treatment strategy designed to act before clinical disease progression.

The decision was supported by results from the Phase III SERENA-6 trial, which evaluated switching endocrine therapy to camizestrant while continuing CDK4/6 inhibition following detection of an emerging ESR1 mutation.

Field	Content
Alert Type	Approval
Drug Name	Camizestrant
Brand Name	Etcamah
Company	AstraZeneca
Regulatory Authority	U.S. Food and Drug Administration
Approval Type	Accelerated approval
Indication	Adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with an ESR1 mutation detected during first-line endocrine-based therapy
Therapy Area(s)	Oncology; breast cancer
Combination	Etcamah plus a CDK4/6 inhibitor
Geography	United States
What Happened	The FDA granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for eligible adults with ESR1-mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer.
Why It Matters	The approval introduces a treatment approach based on detecting emerging ESR1 resistance mutations during first-line therapy and switching endocrine treatment before clinical disease progression.
Supporting Context	The approval was supported by the Phase III SERENA-6 study evaluating camizestrant with continued CDK4/6 inhibition after detection of an ESR1 mutation.
Key Takeaway	Etcamah provides a new FDA-approved treatment option for patients with ESR1-mutated advanced HR-positive, HER2-negative breast cancer identified during first-line therapy.
What to Watch	Clinical uptake of ESR1 mutation monitoring and confirmatory evidence supporting the accelerated approval.
Primary Source	U.S. Food and Drug Administration
Relevant Date	4 September 2026

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