On July 23, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported 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 (Press release, Halozyme, JUL 23, 2025, View Source [SID1234654488]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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. For more information on the study and its findings, please view Johnson & Johnson’s press release issued on July 23, 2025.