On July 23, 2025, the European Commission approved DARZALEX Faspro® (daratumumab), co-formulated with Halozyme's ENHANZE® technology, as monotherapy for adult patients with high-risk smouldering multiple myeloma (SMM). This marks a significant development in the early treatment of multiple myeloma, offering a proactive approach to managing this blood disorder. The approval is based on Phase 3 AQUILA study data and reflects a shift from passive monitoring to early intervention in high-risk cases.
About the New Indication and Disease Context
Smouldering multiple myeloma is an early, asymptomatic stage of multiple myeloma where abnormal plasma cells are present in the bone marrow. While current practice typically involves close observation without treatment, high-risk patients face a greater chance of disease progression. DARZALEX Faspro®, a subcutaneous formulation of daratumumab, now offers an option for earlier therapeutic action, potentially delaying or preventing full-blown disease.
Key Clinical Data Supporting Approval
The EC approval was driven by results from the Phase 3 AQUILA study (NCT03301220). This trial compared fixed-duration subcutaneous daratumumab monotherapy to active monitoring in patients with high-risk SMM. Findings showed that early intervention with DARZALEX Faspro® improved patient outcomes compared to waiting for disease progression. These results support the drug's expanded role across all stages of multiple myeloma treatment.
ENHANZE® Technology and Halozyme's Role
DARZALEX Faspro® is co-formulated with Halozyme's proprietary ENHANZE® drug delivery platform, which uses recombinant human hyaluronidase PH20 (rHuPH20). This technology enables rapid subcutaneous administration, improving patient comfort and reducing infusion time. ENHANZE® is licensed by multiple global pharmaceutical companies and incorporated in over 10 commercial products worldwide, aiming to enhance both convenience and adherence.
About Halozyme Therapeutics
Halozyme is a biopharmaceutical company based in San Diego, specializing in drug delivery solutions and therapeutic devices. Beyond ENHANZE®, it also develops combination products and auto-injector systems. Its partnerships include major pharmaceutical names such as Roche, Pfizer, Janssen, AbbVie, and Takeda. Halozyme continues to expand its technology's application in various therapeutic areas, improving how medicines are delivered and experienced by patients globally.
