In the field of hematologic malignancies, every breakthrough in formulation and delivery technology represents the opening of a new door toward more convenient and safer treatment for patients. Darzalex Faspro® (generic name: daratumumab, subcutaneous injection), with its unique advantage as the world’s first, China’s first, and currently the only subcutaneous anti-CD38 monoclonal antibody formulation, has not only upgraded the treatment paradigm for multiple myeloma but has also filled a long-standing therapeutic gap in the rare disease primary light-chain (AL) amyloidosis. It has brought renewed hope and an improved treatment experience to countless patients with blood cancers. Below, DengyuePharma will explain in detail why this drug is of such critical importance in the treatment of multiple myeloma.

Core Therapeutic Positioning: Dual-Indication Strategy Filling Critical Clinical Gaps

The core active ingredient of Darzalex Faspro® is daratumumab, a humanized anti-CD38 IgG1 monoclonal antibody with a highly targeted mechanism of action. By binding to CD38, which is highly expressed on the surface of tumor cells, daratumumab induces tumor cell apoptosis through multiple immune-mediated mechanisms, including complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC). This precise targeting effectively suppresses tumor progression at its source, achieving an optimal balance between efficacy and safety.

Compared with the conventional intravenous formulation, Darzalex Faspro® represents a major advance in indications, covering two key therapeutic areas and a total of seven indications, thereby establishing comprehensive treatment coverage. On the one hand, it is approved for the full-line treatment of adult patients with multiple myeloma, benefiting both newly diagnosed patients and those with relapsed or refractory disease. On the other hand, it is approved for the treatment of newly diagnosed primary light-chain (AL) amyloidosis (excluding patients with NYHA Class IIIB or IV cardiac disease or Mayo Stage IIIB). As a fatal hematologic disease listed in China’s first rare disease catalog, AL amyloidosis had long faced a “no approved therapy” dilemma prior to the approval of Darzalex Faspro®. Its launch has fundamentally changed this situation, making it the first and only globally approved innovative therapy for this disease.

Innovative Administration: 3–5 Minutes to Treatment Completion, Redefining Convenience

Traditional multiple myeloma therapy has relied heavily on intravenous infusion, which is not only time-consuming (5–7 hours for the first infusion and 3–4 hours for subsequent infusions) but also requires complex dilution and preparation procedures. This places a significant burden on healthcare professionals and subjects patients to prolonged hospitalization, repeated venous access, and increased risks of infection and thrombosis. With its breakthrough subcutaneous administration technology, Darzalex Faspro® has fundamentally addressed these clinical challenges, ushering in a new era of “minutes-level” treatment.

Darzalex Faspro® utilizes a globally innovative drug delivery technology that incorporates recombinant human hyaluronidase (rHuPH20). This enzyme temporarily and locally degrades hyaluronic acid in subcutaneous tissue, overcoming physical tissue barriers and facilitating efficient drug dispersion, penetration, and absorption—providing the essential foundation for subcutaneous administration. The entire injection process is completed in just 3–5 minutes, using a fixed dose of 1,800 mg without the need for weight-based dose calculations. This design reduces dosing errors and avoids drug wastage associated with weight-based intravenous dosing, significantly easing preparation and administration burdens.

More importantly, the subcutaneous route has transformed the treatment setting. Patients no longer require prolonged hospitalization and can receive treatment in outpatient clinics or day wards. This alleviates pressure on hospital bed capacity, improves healthcare resource utilization, and reduces the caregiving burden and time costs for patients and families. Notably, 86% of patients prefer this more convenient treatment approach, significantly improving treatment adherence. In addition, subcutaneous administration avoids large-volume intravenous infusions, offering a safer option for multiple myeloma patients with cardiac or renal comorbidities (approximately 63% with cardiac involvement and 20%–50% with renal involvement), effectively reducing the risk of volume overload associated with intravenous therapy.

Dual Assurance of Efficacy and Safety, Endorsed by Authoritative Guidelines

While delivering greater convenience, Darzalex Faspro® does not compromise efficacy or safety. Its clinical efficacy is comparable to that of the intravenous formulation, with an even more favorable safety profile. Robust evidence from multiple global multicenter clinical trials as well as Chinese studies supports its clinical value. In the COLUMBA study, Darzalex Faspro® monotherapy demonstrated a non-inferior overall response rate (ORR) compared with intravenous daratumumab in patients with relapsed or refractory multiple myeloma (41% vs. 37%). In the APOLLO study, the combination of Darzalex Faspro® with pomalidomide and dexamethasone significantly reduced the risk of disease progression or death by 37% compared with pomalidomide and dexamethasone alone, extending median progression-free survival from 6.9 months to 12.4 months and increasing the overall response rate from 46% to 69%.

From a safety perspective, Darzalex Faspro® shows a clear advantage. Compared with the intravenous formulation, infusion-related reactions are reduced by 62%, and most events are mild to moderate and can be effectively prevented with premedication such as corticosteroids and acetaminophen. The most commonly reported adverse events (≥20%) include respiratory tract infections, neutropenia, and diarrhea, all of which are generally manageable. Its favorable safety profile in special populations further supports its use in patients with cardiac or renal comorbidities.

Thanks to its outstanding efficacy and safety, Darzalex Faspro® has received consistent recommendations from major international and domestic clinical guidelines, including the U.S. NCCN Guidelines, the European ESMO Guidelines, and the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma. These endorsements firmly establish its central role in the treatment of hematologic malignancies.

Clinical Value and Future Outlook: Reshaping Treatment Paradigms, Protecting New Life

The launch of Darzalex Faspro® represents not merely an upgrade in anti-CD38 monoclonal antibody formulation, but a true transformation in the treatment model for hematologic malignancies. With its core strengths of precise targeting, high convenience, and controllable safety, it addresses the longstanding challenges of traditional intravenous therapy—lengthy administration times, complexity, and higher risks—while also filling critical gaps in rare disease treatment. By achieving an integrated balance of efficacy, safety, and convenience, it delivers meaningful clinical value.

From a broader perspective, Darzalex Faspro® offers patients superior treatment options, improves quality of life and survival outcomes, reduces the workload of healthcare professionals, optimizes healthcare resource allocation, and drives the evolution of hematologic cancer treatment toward outpatient-based, convenient, and precision-oriented care.

Currently, Darzalex Faspro® is protected by compound patents (expiring in March 2026) and an indication patent for primary AL amyloidosis (extended through 2036). As an exclusive product in the Chinese market, its unique formulation advantages and comprehensive indication coverage will continue to energize the field of hematologic oncology. Looking ahead, with broader clinical adoption, Darzalex Faspro® is expected to further expand treatment boundaries through combination regimens, bringing renewed hope to more patients with hematologic malignancies and supporting the advancement of diagnostic and therapeutic standards under the “Healthy China” strategy.

From a state of no available treatment to precise therapeutic targeting, from prolonged infusions to completion in minutes, Darzalex Faspro® breaks through clinical limitations with innovation and safeguards patient dignity with human-centered care. It is not merely a drug, but a powerful ally for patients battling blood cancers—bearing witness to the respect for life embodied in medical innovation and opening a new chapter in the treatment of hematologic malignancies.