Shots:
- FDA granted accelerated approval to Etcamah + a CDK4/6 inhibitor for HR+/HER2− LA/M breast cancer with an ESR1 mutation emerging during AI + CDK4/6 inhibitor therapy, alongside approval of a ctDNA-based CDx for detecting ESR1 resistance mutations
- Approval was based on the P-III (SERENA-6) trial assessing Etcamah + CDK4/6 inhibitor vs AI (anastrozole/letrozole) + CDK4/6 inhibitor in 315 pts with locally advanced or metastatic HR+/HER2- breast cancer harboring ESR1 mutation
- Trial showed a 56% reduction in the risk of disease progression or death (mPFS: 16 vs 9.2mos.), plus showed benefit in the time to second disease progression (25.7 vs 19.1mos.) & a favorable OS trend, which is under assessment. Data were published in The NEJM
Ref: Businesswire | Image: AstraZeneca | Press Release
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