Johnson & Johnson‘s DARZALEX® (daratumumab) has received historic approval from the European Commission (EC) to become the first licensed treatment for patients with high-risk smoldering multiple myeloma (SMM). By switching from surveillance to early therapeutic intervention, this move represents a substantial change in the therapy paradigm for this precursor to active multiple myeloma.
The Phase 3 AQUILA research, the biggest randomized trial for a clearly defined high-risk SMM group, produced convincing data that supported the approval. When compared to the standard of care, which is active monitoring, the study showed that fixed-duration treatment with daratumumab considerably decreased the probability of progression to active multiple myeloma or mortality by an astounding 51%.
This new indication for daratumumab SC is an exciting step forward in addressing a long-standing unmet clinical need for those diagnosed with high-risk smouldering multiple myeloma and is the first time a treatment has been approved for this patient population,
EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. “It means that eligible patients no longer have to live with the uncertainty or fear of waiting for progression to occur without active treatment, instead having the option to intercept the disease with therapeutic intervention.
Ester in ’t Groen
Key Findings from the AQUILA Study
- Better Progression-Free Survival (PFS): The active monitoring arm’s median PFS was 22.1 months, whereas the daratumumab arm’s PFS was not attained.
- Improved Overall Survival: Patients receiving daratumumab had a 5-year survival rate of 93.0%, while those under active monitoring had a 5-year survival rate of 86.9%.
- Increased Response Rate: Compared to the active monitoring group, which only had 2.0 percent of patients exhibiting an overall response, the daratumumab group had an astounding 63.4 percent.
A New Era for Patients
Atypical plasma cells can be found in the bone marrow of patients with smouldering multiple myeloma, an asymptomatic, intermediate stage of the disease. It is predicted that within two years, almost half of those with high-risk SMM will develop active multiple myeloma. This patient population had no licensed therapy choices prior to this approval.
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Until now, there have been no approved treatment options for patients diagnosed with high-risk smouldering multiple myeloma,
With today’s approval, Johnson & Johnson has an innovative therapy for every stage of the disease. We can now offer physicians and patients the option to treat with daratumumab earlier, significantly delaying progression and the need for more intensive, continuous therapy, as well as extending overall survival. We remain steadfast in our mission to get in front of cancer.
Jordan Schecter
With a low percentage of treatment discontinuation due to adverse events, daratumumab’s safety profile in the AQUILA study was in line with earlier data. Hypertension was the most frequent Grade 3/4 treatment-emergent adverse event.
With more than 618,000 patients treated globally since its original introduction, daratumumab has emerged as a key treatment for multiple myeloma. Daratumumab’s importance in the early stages of the disease is cemented by this recent approval for the subcutaneous formulation, giving both patients and doctors fresh hope.
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Graduated from the University of Kerala'20 with B.Sc. Botany & Biotechnology. Post-graduation in Biotechnology from the University of Kerala'22. Internship experience in Cancer Research.
