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European Commission Approves Subcutaneous DARZALEX® Treatment

On April 9, 2025, Halozyme Therapeutics, Inc. announced that the European Commission granted approval for an extension of indication for DARZALEX® (daratumumab) administered subcutaneously, co-formulated with its ENHANZE® drug delivery technology. This approval specifically pertains to the regimen that includes DARZALEX® combined with bortezomib, lenalidomide, and dexamethasone (referred to as daratumumab-VRd) for adult patients who have been newly diagnosed with multiple myeloma, regardless of their eligibility for a transplant.

Dr. Helen Torley, President and CEO of Halozyme, emphasized that this expanded use of DARZALEX solidifies its place as an essential treatment option for multiple myeloma patients. By enabling the administration of daratumumab via subcutaneous injection, patients can now experience a more streamlined treatment process that eliminates the need for prolonged intravenous infusions. This not only enhances patient comfort but also aims to improve adherence to therapy by reducing logistical burdens.

This development builds upon a previous approval issued in October 2024 for a similar regimen targeting newly diagnosed patients eligible for autologous stem cell transplant. The success of the regimen was supported by findings from the Phase 3 PERSEUS study (NCT03652064), which demonstrated the efficacy of this quadruplet combination therapy for initial treatment followed by maintenance therapy with daratumumab and lenalidomide.

What Does This Mean for Patients?

The introduction of the subcutaneous formulation of DARZALEX® represents a significant advancement in the management of multiple myeloma, a blood cancer characterized by the uncontrolled growth of plasma cells. By switching to a subcutaneous administration method, patients may benefit from the following:

• - Reduced Treatment Time: Subcutaneous injections are generally quicker than intravenous infusions, allowing for a more efficient treatment session and less time spent in a medical facility.
• - Improved Quality of Life: As noted by Dr. Torley, the ease of subcutaneous administration allows for a more convenient treatment experience, potentially leading to improved overall patient satisfaction and comfort.
• - Broader Access to Effective Therapy: The approval of daratumumab-VRd affirms the drug’s versatility, extending its reach to a broader patient population, particularly those who might have been reluctant to pursue treatment due to the complexities associated with intravenous therapy.

Halozyme's Commitment to Innovation

Halozyme Therapeutics is dedicated to enhancing patient outcomes through innovative technology. At the core of their development is the ENHANZE® platform, which utilizes a proprietary enzyme, rHuPH20, to facilitate the subcutaneous delivery of injectables. This technology has already impacted over one million patients worldwide, being utilized across more than 100 markets and licensed to several major pharmaceutical players like Roche and Takeda.

The company not only leads in developing drug delivery technologies but also focuses on creating combination products that improve patient compliance and comfort. Its current portfolio includes commercial products like Hylenex® and XYOSTED®, with ongoing partnerships aiming to innovate in drug delivery further.

Future Perspectives

Halozyme’s recent approval from the European Commission marks a watershed moment not only for the company but also for the field of oncology. The shift towards subcutaneous administration of critical therapies like DARZALEX is likely to pave the way for further advancements aimed at enhancing patient care in the treatment of various cancers.

In conclusion, the approval of subcutaneous DARZALEX® for multiple myeloma patients illustrates a crucial step forward in the evolution of cancer treatment protocols, emphasizing patient-centric care while ensuring effective management of challenging diseases like multiple myeloma.