What's Happening?
Johnson & Johnson’s Janssen-Cilag has received European Commission approval for its subcutaneous formulation of DARZALEX (daratumumab) as the first authorized treatment for high-risk smouldering multiple myeloma (SMM) in the EU. The approval follows data from the Phase 3 AQUILA trial, which demonstrated that daratumumab monotherapy significantly delayed disease progression and improved overall survival compared to active monitoring. SMM is an intermediate stage of multiple myeloma, where patients may not show symptoms but have abnormal plasma cells in the bone marrow. The approval marks a milestone for J&J’s oncology franchise, extending its therapeutic footprint across all stages of multiple myeloma.
AD
Why It's Important?
The approval of DARZALEX for high-risk SMM represents a significant advancement in the treatment of multiple myeloma, offering a new option for patients who previously had no approved treatments beyond watchful waiting. By intervening earlier in the disease course, the therapy has the potential to delay or prevent progression to symptomatic disease, reduce irreversible organ damage, and improve patient outcomes. This development may shift the standard of care for high-risk SMM, providing patients with the opportunity to intercept the disease with therapeutic intervention.
What's Next?
The approval may lead to changes in how high-risk smouldering myeloma is managed, potentially influencing treatment guidelines and practices in the EU. Johnson & Johnson will likely focus on expanding the availability of DARZALEX and educating healthcare providers about its benefits. The company may also pursue regulatory approval in other regions, further extending its impact on the global treatment landscape for multiple myeloma.
