FDA approves a blood-test-guided switch for a common advanced breast cancer
The FDA on Sept. 4 granted accelerated approval to AstraZeneca's Etcamah (camizestrant), taken with a CDK4/6 inhibitor, for adults with advanced hormone receptor-positive, HER2-negative breast cancer whose tumors develop an ESR1 mutation during standard hormone therapy. The mutation signals growing resistance and is found with an FDA-authorized blood test, so doctors can switch treatment when it appears. In the main trial, switching extended median progression-free survival to 16 months from 9.2 months for those who stayed on standard therapy. The FDA says nearly 40% of patients have the mutation after their disease progresses on an aromatase inhibitor.
The wall: confirmatory evidence owed; OS immature; price
Tier: Confirmed (trial numbers reported)
Sources
- primarynewssource.org/sourcedocument/fda-grants-accelerated-approval-to-a-new-breast-cancer-treatment/
- onclive.com/view/fda-approves-camizestrant-plus-a-cdk4-6-inhibitor-for-emergent-esr1-mutated-hr-her2-advanced-breast-cancer
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