Harpreet Singh, Chief Medical Officer at Precision For Medicine, shared on LinkedIn:
“Etcamah (camizestrant) was recently authorized in the EU based on results from the SERENA-6 trial, creating an important regulatory moment for ER-positive, HER2-negative advanced breast cancer with an ESR1 mutation.
SERENA-6 tested a notable development strategy by switching endocrine therapy after emergence of an ESR1 mutation, before radiographic progression, while continuing CDK4/6 inhibition.
As for the US regulatory pathway, the FDA previously took the application to advisory committee and has since extended its action date to review additional data. We now await FDA’s decision and any additional context that may come with it.
The EU product information also shows how implementation details can become central to label strategy. For Etcamah with any CDK4/6 inhibitor, ECG should be assessed before treatment, around days 8 and 15 of the first cycle, and then as clinically indicated. For Etcamah with ribociclib, electrolytes should also be checked before treatment, at day 15, and as clinically indicated.”
This also can be interesting: SERENA-6: Switching to Camizestrant at ESR1 Mutation Emergence Extends First-Line Benefit in HR+/HER2− Advanced Breast Cancer
