Favourable opinion for reimbursement in the indication as monotherapy “for the treatment of postmenopausal women, and men, with oestrogen 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”.
Clinical Benefit
Moderate
The Committee deems that the clinical benefit of ORSERDU (elacestrant) film-coated tablets is moderate in the MA indication.
Clinical Added Value
no clinical added value
ORSERDU (elacestrant) demonstrated a statistically significant superiority in terms of progression-free survival assessed by an independent review committee in a randomised, open-label phase 3 study versus endocrine therapy alone.
However, considering the following limitations:
The low clinical relevance of this finding, given the point estimate of an absolute difference in median progression-free survival of less than 2 months, combined with the lack of evidence of an effect on overall survival in the final analysis, in a context of advanced disease with an unfavourable prognosis;
The infra-therapeutic nature of the control group. The Committee considers that:
other clinically relevant comparators, which were available on the date of study and have a greater efficacy, could have been used (expert opinion);
a high proportion of patients in the control group who received an aromatase inhibitor (60%) had already received prior therapy with a drug from this therapeutic class. Retreatment following prior failure of this therapeutic class can be considered to be a loss of opportunity compared to the other available comparators (expert opinion);
The absence of any formal conclusion that can be drawn based on the quality of life findings;
Tthe Committee deems thatORSERDU (elacestrant) film-coated tabletsprovides no clinical added value (CAV V) compared to endocrine therapy alone.
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