ELACESTRANT
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Orserdu®
- Form and strength:
-
- Tablet 86 mg (as dihydrochloride)
- Tablet 345 mg (as dihydrochloride)
- Submission sponsor:
- A.MENARINI AUSTRALIA PTY LIMITED
- Condition/indication:
(therapeutic use) -
- Breast cancer
- Listing requested:
- Resubmission to request listing of elacestrant for the treatment of estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) locally advanced or metastatic breast cancer with an activating estrogen receptor 1 mutation in patients who have disease progression following at least one line of endocrine therapy, including at least 12 months of treatment with a cyclin-dependent kinase 4/6 inhibitor. This item was previously considered by the PBAC at its March 2025 meeting.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (Telephone/Online)
- PBAC Submission type:
- New PBS listing (Standard Re-entry Pathway)
- Comment:
- --
- Other PBAC consideration:
Progress Details
-
Submission received for: - July 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
PBAC meeting: - Held on 08/07/2026
-
PBAC outcome published: - Not Recommended (see PBAC Outcomes)
-
Lodgement of required documentation: - Not applicable
-
Agreement to listing arrangements: - Not applicable
-
Government processes: - Not applicable
-
Medicine listed on the PBS: - Not applicable
PBAC Outcome
The PBAC did not recommend elacestrant (Orserdu®) for the treatment of estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) locally advanced or metastatic breast cancer with an activating estrogen receptor 1 (ESR1) mutation in patients whose disease has progressed following at least one line of endocrine therapy, including at least 12 months of treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i).
The PBAC previously considered elacestrant for this population at its March 2025 meeting. At that time, the PBAC did not recommend listing, and advised the supplying company that a resubmission should clarify the clinical place of elacestrant and provide evidence that it is more effective than the standard of care for the requested patient population.
The PBAC welcomed input from healthcare professionals and organisations and recalled the input it received in March 2025. The input highlighted there is some clinical need for alternative treatments for ER+/HER2- locally advanced or metastatic breast cancer that have fewer adverse effects or that allow patients to avoid or delay the use of chemotherapy.
The supplying company’s July 2026 resubmission nominated everolimus with exemestane as the relevant standard of care for second and later lines of treatment. The PBAC did not agree this was the right treatment to compare to elacestrant, because it is not often used in patients whose disease has progressed after treatment with a CDK4/6i.
The PBAC considered the evidence presented in the resubmission did not allow confidence that elacestrant would enable patients to live longer without cancer progression, or cause fewer adverse events, than treatment with everolimus with exemestane. This was because the resubmission compared some patients from the elacestrant trial with a small number of patients from a registry who had used everolimus with exemestane. This meant the differences in cancer progression could be due to factors other than the true differences in effectiveness between elacestrant and everolimus with exemestane.
Consequently, the PBAC did not consider elacestrant would be cost-effective at the proposed price, because the clinical evidence did not adequately support the sponsor’s estimated benefits over everolimus and exemestane.
Sponsor’s Comment:
The sponsor had no comment.