The European Commission (EC) has approved the extension of indication for Janssen-Cilag International’s Darzalex (daratumumab) subcutaneous (SC) formulation to be used in the frontline setting for treating newly diagnosed multiple myeloma (NDMM) in adults.
Janssen-Cilag is a Johnson & Johnson (J&J) company.
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The approval allows for the use of daratumumab SC in conjunction with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd).
The therapy currently holds nine indications approved for multiple myeloma (MM) with five for frontline treatment, including regimens for patients both eligible and ineligible for autologous stem-cell transplant (ASCT).
The latest approval follows October 2024’s indication extension for daratumumab-VRd to treat newly diagnosed patients eligible for ASCT, supported by the Phase III PERSEUS trial results.
The trial focused on assessing the therapy’s SC-based quadruplet regimen for consolidation and induction therapy with daratumumab SC and lenalidomide maintenance.
The trial assessed the safety and efficacy of daratumumab-VRd against VRd in NDMM subjects who were either transplant ineligible or for whom ASCT was not intended as initial treatment.
Daratumumab-VRd’s overall safety profile was consistent with the known profiles of daratumumab SC and VRd.
Johnson & Johnson innovative medicine EMEA therapeutic area haematology lead Edmond Chan stated: “Daratumumab has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-cluster of differentiation 38 (CD38) antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility.
“This latest approval confirms the enhanced benefit of daratumumab SC-based quadruplet regimens and its versatility and effectiveness in addressing the diverse needs of those affected by this complex disease.”
J&J also filed a supplemental biologics licence application with the US Food and Drug Administration in September 2024 for a new indication for daratumumab SC with VRd to treat adults with NDMM who are either ineligible for ASCT or for whom ASCT is deferred.
In 2024, the company announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex-based quadruplet therapy for MM.
In 2012, J&J’s Janssen Biotech and Genmab entered a global agreement granting J&J exclusive development, manufacturing and commercialisation rights for daratumumab.
