EC approval for subcutaneous Darzalex
Slightly more than a month after the US Food and Drug Administration approved the product, the European Commission (EC) has also granted marketing authorization for Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma (MM), says US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Janssen subsidiary.
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 (13% versus 35%, respectively).
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