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) +…
Shots:
The EC has approved Etcamah + a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for adults with ER+, HER2- locally advanced or metastatic breast cancer with an ESR1 mutation & no progression on 1L endocrine therapy + CDK4/6 inhibitor; regulatory review is ongoing in the US
Approval was based on the P-III (SERENA-6) trial assessing…

