AIFA approves belantamab mafodotin for multiple myeloma in Italy

The Italian Medicines Agency (AIFA) has approved the availability of belantamab mafodotin in Italy for the treatment of patients with multiple myeloma at first relapse. Developed by GSK, the drug is used in two therapeutic combinations: one with bortezomib and dexamethasone, and another with pomalidomide and dexamethasone.

Clinical trials Dreamm-7 and Dreamm-8 demonstrated significant efficacy. In the Dreamm-7 study, the combination tripled the median progression-free survival (PFS) to 36.6 months compared to 13.4 months for the standard of care, while reducing the risk of death by 42%. The Dreamm-8 study showed an increase in disease-free survival to 32.6 months compared to 12.5 months in the control group. GSK noted that approximately 400 patients have already been receiving the drug through access programs in nearly all hematology centers.