Matthew Kurian, Assistant Professor of Medicine at the University of Kentucky College of Medicine and Physician at St. Elizabeth Healthcare, shared a post on LinkedIn:
“Breaking: ODAC Votes 6-3 Against Camizestrant Approval (SERENA-6)
The FDA advisory committee did not support approval of camizestrant based on SERENA-6, citing several key concerns:
- Unclear benefit of switching therapy at ESR1 mutation detection vs waiting for progression
- Questions around the clinical meaningfulness of PFS measured from ESR1m detection. PFS2 not deemed an acceptable endpoint in this specific study.
- OS immature and unlikely to definitively answer long-term benefit. Data so far showing curves overlapping.
- No clear improvement in chemo/ADC-free survival or PROs
- Signal for cardiac toxicity in the setting of uncertain benefit
Takeaway:
ctDNA is changing how we detect resistance—but acting earlier does not yet clearly translate into better outcomes.
A close vote, but a strong reminder: earlier intervention must still prove meaningful clinical benefit.”
AstraZeneca’s Camizestrant Faces FDA ODAC Review In ESR1-Mutated HR+/HER2− Breast Cancer 