Simon Blanc, Director of the Cancer Center and Hematology-Oncology at Broward Health Medical Center, shared on LinkedIn:
“A drug that already worked alone just got a partner – and the combination changes the sequencing conversation in ER-positive breast cancer.
The FDA just granted full approval to imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that has progressed on endocrine therapy.
This isn’t a first approval – imlunestrant already held monotherapy approval in this exact ESR1-mutated population. What’s new is the partner. In the Phase 3 EMBER-3 trial, imlunestrant plus abemaciclib cut the risk of progression or death by 38% versus endocrine therapy alone, with a median PFS of 11.1 months after switching regimens at progression.
The practical shift: ESR1 mutation testing at progression is no longer just a marker for which oral SERD to reach for – it’s now a fork in the road between monotherapy and a CDK4/6-inclusive combination, with the Guardant360 CDx assay approved alongside it as the companion diagnostic.
For a mutation most of us are already testing for reflexively, the question isn’t whether to test anymore. It’s which regimen the result should actually trigger.
Are you defaulting to the combination, or reserving it for a specific subset of your ESR1-mutated patients?”
This also can be interesting:
