ELACESTRANT

Information current as at: 1 June 2026

PBAC meeting date: July 2026

Legend:

Completed N In progress

Not applicable N Yet to commence

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 (–)
Comment:: --
Other PBAC consideration:: ELACESTRANT

Submission received for:: July 2026 PBAC meeting
Opportunity for consumer comment:: Open 25/03/2026 and close 20/05/2026 (see PBS Website)
3PBAC meeting:: Has not yet occurred
4PBAC outcome published:: Pending PBAC outcome (see PBAC Outcomes)
5Lodgement of required documentation:
6Agreement to listing arrangements:: Has not yet commenced
7Government processes:: Has not yet commenced
8Medicine listed on the PBS:: Has not yet occurred

PBAC Recommendation:

Please see the Outcomes from the relevant meeting for more information

Case ID

1225

Page last updated

31 May 2026

v.9.19