Halozyme Therapeutics, Inc. has announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval of a new indication for DARZALEX Faspro (daratumumab) co-formulated with ENHANZE, as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma.

“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.”

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 (or ‘Watch and Wait’) to track for signs of biochemical progression and/or end-organ damage. This means therapeutic intervention is only offered when the disease progresses.

The EC approval is supported by data from the Phase 3 AQUILA study (NCT03301220), evaluating the efficacy and safety of fixed-duration monotherapy daratumumab SC compared with active monitoring in those with high-risk SMM.