VERZENIOS (abémaciclib) - Traitement adjuvant du cancer du sein précoce avec (RH) positifs

Key points

Disapproval of reimbursement for the following indication:

VERZENIOS (abemaciclib) in association with hormone therapy is indicated for adult patients in adjuvant treatment of early-onset hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, with lymph node involvement, and high risk of recurrence.

For pre/perimenopausal women, aromatase inhibitor hormone therapy must be associated with a luteinising hormone-releasing hormone (LHRH) agonist.

Role in therapeutic strategy?

Role of VERZENIOS (abemaciclib) in the therapeutic strategy:

Considering:

• the evidence, despite being statistically significant, of the superiority of abemaciclib in association with standard hormone therapy versus standard hormone therapy alone in terms of invasive disease-free survival, which has limitations as to the effect size which remains clinical small on this outcome measure in terms of absolute gain (95.2% vs 93.4%; Δ = 1.8 points), and the unsuitability of this outcome measure as a substitute for overall survival based on current knowledge;
• the lack of data on overall survival considering the duration of the study;
• the safety profile, characterised by gastrointestinal disorders, thromboembolic events and infections, similar to that observed in advanced breast cancer. However, the acceptability of adverse effects is lower in this context of early-stage adjuvant treatment;

The Committee deems, based on the data currently available, that VERZENIOS (abemaciclib) has no role in the therapeutic strategy in association with hormone therapy in the adjuvant treatment of adult early-onset HR+/HER2- breast cancer patients, with lymph node involvement and high risk of recurrence.