Advice

following a full submission assessed under the end of life and orphan equivalent medicine process:

elacestrant (Korserdu®) is not recommended for use within NHSScotland.

Indication under review: as monotherapy for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.

In an open-label phase III study, elacestrant significantly improved progression-free survival compared with investigator’s choice of endocrine monotherapy in adults with ER-positive, HER2-negative, locally advanced or metastatic breast cancer with an ESR1 mutation who had disease progression after at least one line of treatment including a CDK 4/6 inhibitor plus endocrine therapy.

The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Medicine details

Medicine name:
elacestrant (Korserdu)
SMC ID:
SMC2807
Indication:

Treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.

Pharmaceutical company
Menarini Stemline
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Not recommended
Date advice published
10 November 2025