European Commission Approves Darzalex Injectable for Smouldering Multiple Myeloma

Johnson & Johnson announced that the European Commission approved an injectable version of its blood cancer therapy Darzalex for smouldering multiple myeloma. Developed with Halozyme Therapeutics and Genmab, the treatment affects nearly 100,000 people worldwide, who are asymptomatic but at risk of progression to multiple myeloma. The approval is expected to help patients with smouldering multiple myeloma and provide an alternative to existing treatments.

The European Commission (EC) has approved the injectable version of Johnson & Johnson's blood cancer therapy Darzalex Faspro for the treatment of adult patients with smouldering multiple myeloma (SMM) at high risk of progression to active multiple myeloma. This landmark approval marks a significant advancement in early intervention for multiple myeloma, offering a new treatment paradigm for patients with high-risk smouldering disease [1][2].

DARZALEX Faspro® is co-formulated with Halozyme's ENHANZE® drug delivery technology, which facilitates rapid subcutaneous delivery of the injected drug. The approval is based on the results of the Phase 3 AQUILA study, which demonstrated that fixed-duration treatment with daratumumab significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring [1][2].

SMM is an asymptomatic intermediate disease state of multiple myeloma where abnormal cells can be detected in the bone marrow. The current standard of care for SMM, even in high-risk cases, is active monitoring, which means therapeutic intervention is only offered when the disease progresses. The EC approval of DARZALEX Faspro offers a new treatment option for patients with high-risk SMM, allowing for earlier intervention and potentially delaying or preventing progression to symptomatic disease [1][2].

The Phase 3 AQUILA study evaluated the efficacy and safety of fixed-duration monotherapy daratumumab SC compared to active monitoring in patients with high-risk SMM. The study showed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) in the daratumumab arm compared to active monitoring [1][2].

"This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "We are pleased that the new treatment paradigm addresses the critical needs of people living with this complex blood disease" [1].

The approval of DARZALEX Faspro for SMM is expected to help patients with smouldering multiple myeloma and provide an alternative to existing treatments. This approval is a significant step forward in addressing a long-standing unmet clinical need for those diagnosed with high-risk smouldering multiple myeloma [1][2].

References:
[1] https://www.prnewswire.com/news-releases/european-commission-approved-darzalex-faspro-for-adult-patients-with-smouldering-multiple-myeloma-302512103.html
[2] https://www.globenewswire.com/news-release/2025/07/23/3120055/0/en/European-Commission-approves-DARZALEX-daratumumab-as-the-first-licensed-treatment-for-patients-with-high-risk-smouldering-multiple-myeloma.html