PBAC's latest decision on Elacestrant: Recommended with restriction (2025). Considered for Locally advanced or metastatic breast cancer in men and postmenopausal women with ER+/HER2- disease, an activating ESR1 variant, and disease progression following at least one line of endocrine therapy including a CDK4/6 inhibitor.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Men and postmenopausal women with ER+/HER2- locally advanced or metastatic breast cancer with an activating ESR1 variant who have disease progression following at least one line of endocrine therapy including a CDK4/6 inhibitor.
Therapy area
Oncology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
EMERALD
Comparator
standard of care (fulvestrant or aromatase inhibitor monotherapy)
Economic model
CUA
ICER note
ICER value not stated in the provided text; document text is incomplete at section 5.