KYPROLIS (carfilzomib), antineoplastic

High clinical benefit in combination with lenalidomide and with dexamethasone for multiple myeloma in patients having previously received at least one treatment line and moderate clinical added value compared to the lenalidomide and dexamethasone combination

• KYPROLIS has been granted a marketing authorisation in combination with lenalidomide and with dexamethasone alone for the treatment of multiple myeloma in adults who have received at least one prior treatment. Its tritherapy dosage is different to that for bitherapy.

• The superiority of the tritherapy combining KYPROLIS with lenalidomide and with dexamethasone over the lenalidomide plus dexamethasone combination has been demonstrated in terms of progression-free survival (absolute gain of 8.7 months) and overall survival (absolute gain of 7.9 months).

• Cardiac disorders (onset and/or worsening of heart failure, myocardial ischaemia, and myocardial infarction), haematological disorders (particularly thrombocytopoenia), hydroelectrolytic disorders (hypokalaemia) and thromboembolic events have been reported more frequently during treatment with carfilzomib/lenalidomide/dexamethasone than in the case of lenalidomide/dexamethasone. The incidence of heart failure is also more frequent with the carfilzomib/lenalidomide/dexamethasone combination than with lenalidomide/dexamethasone: 6.4% versus 4.1%.

• Cardiac monitoring is advised for patients treated with KYPROLIS, regardless of the dosage schedule.