VERZENIOS (abemaciclib) - HR-positive/HER2-negative early breast cancer

The Committee deems that the clinical benefit of VERZENIOS (abemaciclib) is moderate in the MA indication.

Considering:

• demonstration of a superiority of abemaciclib in combination with standard endocrine therapy compared to standard endocrine therapy alone in terms of invasive disease-free survival (IDFS) in the primary analysis and the suggested maintenance of the effect after a median follow-up of 42 months, with a modest difference of 5.6 points and an effect on distant recurrences primarily; but the impossibility of considering this outcome measure as a substitute for an overall survival endpoint as knowledge currently stands; 
• the lack of evidence of an improvement in overall survival to date (immature data for this endpoint);
• the safety profile, characterised by gastrointestinal disorders, thromboembolic events and infections, particularly at the start of treatment;

the Committee deems that VERZENIOS (abemaciclib) provides no clinical added value (CAV V) compared with standard endocrine therapy alone.