Daratumumab (12) – Darzalex®

• Clinical trials
  • To assess the additional benefit of daratumumab in combination with bortezomib, lenalidomide and dexamethasone compared with the appropriate comparator therapy, the pharmaceutical manufacturer submitted the ongoing, open-label, randomised PERSEUS trial.

Adults with newly diagnosed multiple myeloma who are suitable for autologous stem cell transplantation

• The additional benefit is not proven.
• Overall, the induction and consolidation therapy with VRd administered in the control arm of the PERSEUS trial does not correspond to the appropriate comparator therapy as defined by the G-BA. Consequently, the appropriate comparator therapy has not been implemented in the PERSEUS trial. Consequently, the PERSEUS study is not suitable for assessing the additional benefit of daratumumab + bortezomib + lenalidomide + dexamethasone compared with the appropriate comparator therapy.
• Consequently, there are no suitable data available to enable an assessment of the additional benefit, which is why an additional benefit of daratumumab in combination with bortezomib, lenalidomide and dexamethasone in the treatment of patients with newly diagnosed multiple myeloma, who are suitable for autologous stem cell transplantation, proof that they are suitable has not been proven.

Courtesy translation only, please refer to the German original.