1 March 2017 - More frequent severe side effects in first-line therapy after menopause/missing data for other patients.
Palbociclib (Ibrance) has been approved since November 2016 for the treatment of women with advanced hormone receptor-positive breast cancer who are ineligible for chemotherapy, radiation therapy or surgery. The IQWiG has examined in an early benefit assessment whether palbociclib offer advantages over the appropriate comparison therapies.
Such use is thus not proven: for several groups of patients, the dossier does not contain any suitable data. Palbociclib, when used in combination with letrozole, is more likely to have severe side effects than the use of letrozole alone, where there are data, namely, post-menopausal post-menopausal therapy, indicating a lesser benefit.