Posted by Michael Wonder on 16 Apr 2019
Ribociclib in advanced breast cancer: survival benefits, but also severe side effects
15 April 2019 - In the overall view, an added benefit is not proven.
As early as 2017, the IQWiG examined the advantages and disadvantages of ribociclib in combination with an aromatase inhibitor for patients with HR- positive, HER2- negative, locally advanced or metastatic breast cancer compared to the ACT. At that time it was about the use as an initial endocrine-based therapy in postmenopausal women. The study data did not show a statistically significant advantage, but rather strong side effects of the new combination, so that the conclusion was ribociclib, together with an aromatase inhibitor, has a lower benefit than the appropriate comparator therapy .
Meanwhile, the application of ribociclib has also been extended to women before or during menopause. The active ingredient can be combined not only with an aromatase inhibitor but also with fulvestrant. And it must not only be used initially, but also as a follow-up therapy. Therefore, the Federal Joint Committee (G-BA) commissioned IQWiG with a new dossier assessment based on data from the MONALEESA-3 and MONALEESA-7 studies.
