Severe side effects in first–line treatment after menopause more frequent / no data for other patients.

Palbociclib (trade name: Ibrance) has been approved since November 2016 for the treatment of women with advanced hormone receptor–positive breast cancer who are not eligible for chemotherapy, radiotherapy or further surgery. In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) investigated whether this drug offers advantages for patients over the appropriate comparator therapies.

According to the findings, such an added benefit is not proven: The dossier contained no data or no suitable data on several groups of patients. Where data were available, i.e. in the first–line treatment after menopause, severe side effects were more frequent under palbociclib in combination with letrozole than under letrozole alone, which resulted in an indication of lesser benefit.