#United States #San Diego #Halozyme #DARZALEX FASPRO #Janssen-Cilag

New Hope for Patients: DARZALEX Faspro® Approved for High-Risk Smouldering Multiple Myeloma

On July 23, 2025, a significant breakthrough in the fight against multiple myeloma was announced as the European Commission granted approval for the use of DARZALEX Faspro® (daratumumab) in adults diagnosed with smouldering multiple myeloma (SMM) who are at high risk of progressing to full-blown multiple myeloma. This approval, achieved by Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, represents a pivotal step toward advanced treatment options for this complex blood disease.

What is Smouldering Multiple Myeloma?

Smouldering multiple myeloma is a precursor stage of the more aggressive multiple myeloma. Patients typically exhibit abnormal cells in the bone marrow but do not show symptoms. Currently, the standard care for patients with SMM, even those at high risk, is active monitoring known as 'Watch and Wait.' This approach allows physicians to keep track of potential progress or complications, postponing treatment until the disease escalates.

The newly approved DARZALEX Faspro® provides a proactive treatment option that could potentially alter this passive approach, allowing for earlier intervention in patients who desperately need it.

Breakthrough Technology

The approval is underpinned by the Phase 3 AQUILA study, which explored the efficacy and safety of the drug as a monotherapy in comparison to active monitoring among individuals with high-risk smouldering multiple myeloma. Officials from Halozyme Therapeutics, the company behind the drug’s unique formulation, have highlighted the importance of this move. “This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma,” said Dr. Helen Torley, the President and CEO of Halozyme.

The incorporation of Halozyme's ENHANZE® drug delivery technology enhances the administration of daratumumab by allowing for subcutaneous injection, which significantly improves the patient experience, making treatment less burdensome.

Impact on Patients

The prospect of receiving early treatment is a welcome narrative for individuals diagnosed with SMM. With data from AQUILA indicating improvements in outcomes, patients and healthcare providers can now consider a course of action much sooner than before. The innovative delivery method offered by ENHANZE® aims to reduce the time spent on treatment while potentially improving overall health outcomes.

Patients currently facing the wait-and-see approach now have a promising alternative, ensuring that those at greater risk of progression receive timely and adequate treatments for better management of their health.

About Halozyme

Halozyme Therapeutics, Inc. is a biopharmaceutical company committed to developing pioneering solutions to enhance therapy experiences and patient outcomes. Their innovative ENHANZE® platform allows for more efficient drug delivery methods that will potentially become standard across various therapies. Encompassing a broad array of partnerships, including collaborations with pharmaceutical giants such as Roche, Pfizer, and AbbVie, Halozyme continues to push the boundaries of treatment possibilities.

As they look toward the future, Halozyme is focused on further expanding their product range while ensuring that their technology enhances patient comfort and adherence during treatment processes.

For more information about their initiatives, visit Halozyme's official website and follow them on their social media platforms. This advancement in treatment for individuals with high-risk smouldering multiple myeloma marks a significant leap forward in the ongoing battle against this challenging disease.