The European Commission (EC) has granted marketing authorisation for daratumumab (Darzalex®) subcutaneous (SC) formulation for the treatment of adult myeloma patients. Daratumumab SC is administered as a fixed dose, which significantly reduces treatment time, from hours to approximately three to five minutes, when compared to daratumumab intravenous (IV) formulation.
In addition, only the first dose of daratumumab SC needs to be administered in an environment where resuscitation facilities are available. The approval applies to all current daratumumab indications in frontline and relapsed/refractory settings, and patients currently on daratumumab IV can switch to the SC formulation should they choose to.
Data supporting the approval show that daratumumab SC demonstrated a consistent overall response rate (ORR) and a similar safety profile compared with daratumumab IV in patients with relapsed or refractory MM. In addition, there was a nearly two-thirds reduction in systemic infusion-related reactions (IRRs) for daratumumab SC compared to daratumumab IV.
“Multiple myeloma is an incurable blood cancer that is often associated with time-intensive treatment regimens, which can be burdensome for patients and physicians. Today’s approval marks important progress for the oncology community as it means daratumumab can now be administered in significantly less time, thereby reducing the time patients need to be in the clinical setting,” said Maria-Victoria Mateos, M.D., Ph.D., COLUMBA primary investigator and Director of the Myeloma Unit at University Hospital of Salamanca-IBSAL, Salamanca, Spain. “Given the current health climate, this is timely and welcome news, particularly for immunocompromised patients.”
Read the complete press release here.