Documentary record · ACCELERATED APPROVAL

Camizestrant (Etcamah) receives accelerated approval for ESR1-mutated breast cancer, guided by a blood test

ACCELERATED APPROVAL — CONFIRMATORY EVIDENCE REQUIRED

Event date

September 4, 2026

Jurisdiction

United States

Issuing body

U.S. Food and Drug Administration

Action type

ACCELERATED APPROVAL

Lifecycle state

ACCELERATED APPROVAL — CONFIRMATORY EVIDENCE REQUIRED

Verification date

15 September 2026

An accelerated approval: continued approval may depend on verification of clinical benefit. FDA also approved the Guardant360 CDx blood test as the companion diagnostic.

What this establishes

  • FDA granted accelerated approval to camizestrant with a CDK4/6 inhibitor for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer when an ESR1 mutation is detected during aromatase-inhibitor plus CDK4/6-inhibitor therapy.
  • The indication permits switching on detection of the mutation in circulating tumour DNA, before imaging shows progression — described as a first for a cancer therapy.
  • Efficacy came from the SERENA-6 trial. FDA’s Oncologic Drugs Advisory Committee had voted 6–3 against in April 2026.
  • The prescribing information includes a boxed warning for arrhythmia risk when taken with certain other medicines.

What this does not establish

  • That switching at molecular progression improves long-term survival; that question remains open.
  • Coverage or reimbursement.

Why it matters

This approval tests how far a surrogate measured in blood can carry a treatment decision, and it went forward despite a negative advisory vote — both central questions in accelerated-approval policy.

Primary source

Register: the record store · record id fda-camizestrant-accelerated-approval-2026-09-04.