EU approves subcutaneous daratumumab combo for newly diagnosed multiple myeloma

European Commission approves subcutaneous daratumumab quadruplet therapy for newly diagnosed multiple myeloma

BEERSE, BELGIUM: The European Commission has officially approved the subcutaneous Daratumumab-based quadruplet regimen—a groundbreaking treatment for adults with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplantation (ASCT). This decision marks a significant advancement in multiple myeloma treatment, offering a more convenient and potentially safer administration method with high efficacy.

What is subcutaneous daratumumab?

Daratumumab (brand name: DARZALEX®), developed by Johnson & Johnson’s Janssen Pharmaceutical Companies, is a monoclonal antibody targeting CD38, a surface protein commonly found on multiple myeloma cells. The subcutaneous formulation—a quick injection under the skin—offers a time-saving alternative to the traditional intravenous (IV) route, with similar therapeutic outcomes and improved patient convenience.

Approved regimen overview

The approved quadruplet regimen includes:

• Daratumumab (SC)
• Bortezomib
• Thalidomide
• Dexamethasone

The combination is intended for newly diagnosed patients undergoing ASCT, and it’s the first subcutaneous CD38-directed antibody therapy to be approved in this setting within the European Union.

Key clinical evidence: The PERSEUS study

The European Commission’s decision was based on the results of the Phase 3 PERSEUS trial, which showed:

• Significantly deeper and more durable responses with the Daratumumab quadruplet.
• A higher rate of MRD (Minimal Residual Disease) negativity, indicating superior disease control.
• No new safety concerns, and a reduction in infusion-related reactions compared to IV administration.

Expert insight:

“This approval sets a new benchmark for how we approach frontline therapy in multiple myeloma,” said Dr. Thierry Facon, Principal Investigator of the PERSEUS study.

Why this matters: Clinical and patient impact

• Improved convenience: Subcutaneous administration reduces chair time and patient burden.
• Broader accessibility: Easier to administer across outpatient clinics.
• Enhanced quality of life: Less time in treatment centers and fewer side effects from prolonged infusions.

What’s next for daratumumab?

Janssen plans to expand access and education across EU member states and is exploring further combination regimens and indications. The drug has already seen broad uptake in the US and other global markets.