KYPROLIS (carfilzomib), antineoplastic

High clinical benefit in combination with dexamethasone alone for multiple myeloma in patients having previously received at least one treatment line and minor clinical added value compared to the bortezomib and dexamethasone combination in the therapeutic strategy.

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

• The superiority of the bitherapy combining KYPROLIS with dexamethasone over the bortezomib + dexamethasone combination has been demonstrated in terms of progression-free survival (absolute gain of 9.3 months). A 21% reduction in the risk of death compared to the bortezomib plus dexamethasone combination has been observed.

• The KYPROLIS + dexamethasone combination increases the risk of heart failure compared to the bortezomib + dexamethasone combination: 8.6% versus 3.3% and in particular a decrease in the ventricular ejection fraction of 2.4% versus 0.9%.

• Screening for potential heart disorders is required in order to set up treatment, particularly by means of echocardiography, and all patients should be monitored during treatment to detect signs of fluid overload, particularly patients presenting with a risk of heart failure.