Johnson & Johnson's Janssen unit announced a significant advancement in multiple myeloma treatment as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval for DARZALEX® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for newly diagnosed patients.
Clinical Trial Success Drives Recommendation
The positive opinion is based on data from the Phase 3 CEPHEUS study, which enrolled 395 patients across 13 countries. The trial evaluated daratumumab-VRd against standard VRd treatment in patients who were either transplant-ineligible or had deferred transplantation. The study's primary endpoint focused on overall Minimal Residual Disease (MRD) negativity rate, with participants ranging in age from 31 to 80 years (median age 70).
"It is increasingly evident that to continue optimising outcomes in multiple myeloma, we must intervene early with the most effective therapies first," stated Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology at Johnson & Johnson Innovative Medicine.
Expanding Treatment Landscape
DARZALEX® has established itself as a cornerstone therapy in multiple myeloma treatment, with current approval in eight indications, including four in the frontline setting. The drug's mechanism of action targets CD38, a surface protein highly expressed on multiple myeloma cells, leading to tumor cell death through multiple mechanisms.
The subcutaneous formulation represents a significant advancement in drug delivery, co-formulated with Halozyme's ENHANZE® technology to improve administration efficiency. This latest recommendation builds upon the October 2024 approval for transplant-eligible patients, further expanding the treatment options across the patient spectrum.
Disease Impact and Market Significance
Multiple myeloma continues to present a significant health challenge in the European Union, with over 35,000 new diagnoses and 22,700 deaths recorded in 2022. The disease, which affects plasma cells in the bone marrow, remains incurable but treatable, with symptoms ranging from bone pain and fractures to fatigue and increased infection risk.
Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma at Johnson & Johnson Innovative Medicine, emphasized the company's commitment: "For almost a decade, daratumumab has transformed the standard of care in multiple myeloma, and we have remained steadfast in our commitment to continue improving outcomes for all patients with this complex disease."
Regulatory Progress
Beyond the European recommendation, Johnson & Johnson has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration, seeking approval for the same indication in transplant-ineligible or deferred patients. This global regulatory strategy reflects the company's commitment to expanding access to innovative multiple myeloma treatments worldwide.
