Brazil Approved AstraZeneca’s Camizestrant 17 Days After the FDA, Whose Own Advisers Had Voted Against It
- Anvisa approved Etcamah (camizestrant) from AstraZeneca on 21 September 2026 for adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer after an ESR1 mutation emerges during at least six months of first-line endocrine therapy with a CDK4/6 inhibitor, and before radiological or clinical progression.
- In SERENA-6, which randomised 315 patients, switching to camizestrant at mutation detection gave median progression-free survival of 16 months against 9.2 months on continued aromatase inhibitor (hazard ratio 0.44), with overall survival immature, according to the FDA.
- The FDA granted accelerated approval on 4 September, alongside the Guardant360 CDx test, after its oncology advisory committee voted 6 to 3 in April that the trial had not shown clinically meaningful benefit. The EU approved it in July. The US label carries a boxed warning for arrhythmia risk with QTc-prolonging drugs.
- Ten minutes after the approval notice, Anvisa ordered the seizure of a counterfeit batch of Roche‘s Phesgo, batch B5011B05 made in June 2025, which Roche itself reported, along with counterfeit batches of Ipsen’s Dysport.
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Every major regulator has now said yes to a strategy the FDA’s advisers doubted. The competition that follows is over timing, and the constraint is a blood test.
- Project Orbis carried the approval, and the caveat travels with it. The FDA reviewed camizestrant alongside Anvisa, Australia, Canada, Singapore and Switzerland. The US approval is accelerated, based on progression-free survival measured from mutation detection, and depends on confirmatory evidence. Anvisa’s notice does not say whether its registration carries equivalent conditions.
- The ESR1 timeline now has two owners in the US. AstraZeneca’s camizestrant switches at mutation emergence before progression. Lilly’s Inluriyo with Verzenio, fully approved on 18 September, treats after progression. Both run through the same Guardant360 CDx test, so every patient caught earlier by monitoring is one AstraZeneca reaches before Lilly’s line of therapy begins.
- In Brazil the constraint is the monitoring, not the molecule. Fewer than 5% of patients carry an ESR1 mutation at metastatic diagnosis and nearly 40% acquire one after progression on an aromatase inhibitor, according to the FDA and AstraZeneca. Capturing that switch means serial ctDNA testing across the first-line population, and who pays for it will decide uptake more than the drug’s price.