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European Commission Approves J&J's Darzalex Regimen for Newly Diagnosed Multiple Myeloma

• The European Commission has approved Johnson & Johnson's Darzalex subcutaneous formulation for newly diagnosed multiple myeloma (NDMM). • Darzalex, combined with bortezomib, lenalidomide, and dexamethasone (VRd), is authorized for NDMM patients eligible for autologous stem cell transplant (ASCT). • The approval was based on the PERSEUS study, which showed a 58% reduction in disease progression or death compared to VRd alone. • Darzalex targets the CD38 protein on myeloma cells, enhancing immune response and improving patient outcomes in the frontline treatment of multiple myeloma.

The European Commission (EC) has granted approval to Johnson & Johnson's (J&J) subcutaneous (SC) formulation of Darzalex (daratumumab) for use in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of newly diagnosed multiple myeloma (NDMM) in patients eligible for autologous stem cell transplant (ASCT). This decision marks a significant advancement in the treatment landscape for this patient population.
The approval is based on the positive results of the Phase 3 PERSEUS study, a randomized trial involving over 700 ASCT-eligible NDMM patients. The study compared the Darzalex SC plus VRd regimen as induction and consolidation therapy, followed by Darzalex SC and lenalidomide maintenance, against VRd induction and consolidation followed by lenalidomide maintenance.

Significant Reduction in Disease Progression

The Darzalex-based regimen demonstrated a significant reduction in the risk of disease progression or death by 58% compared to VRd alone (p<0.0001) after a median follow-up of 47.5 months. The study also showed that the Darzalex combination led to deeper responses, indicating a more effective eradication of myeloma cells.

Mechanism of Action and Clinical Impact

Darzalex is a monoclonal antibody designed to target the CD38 protein, which is highly expressed on multiple myeloma cells. By binding to CD38, Darzalex activates the immune system to eliminate these abnormal white blood cells. This targeted approach has proven effective in improving outcomes for patients with multiple myeloma.
Edmond Chan, Senior Director, EMEA Therapeutic Area Lead Haematology, Innovative Medicine, J&J, stated, "The EC’s approval of this [Darzalex] quadruplet regimen marks a pivotal step forward in the treatment of NDMM. By incorporating [Darzalex] SC into this regimen we are further optimising frontline therapy for patients, building on our aim to transform outcomes, and establish new standards of care for eligible patients from induction through to maintenance."

Multiple Myeloma Burden

In 2022, over 35,000 individuals in the EU were diagnosed with multiple myeloma, an incurable blood cancer affecting plasma cells. This approval offers a new, more effective treatment option for these patients, potentially improving their quality of life and extending survival.
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J&J Seeks Approval for Subcutaneous Darzalex in Smoldering Multiple Myeloma

Johnson & Johnson has submitted applications to the EMA and FDA for subcutaneous Darzalex (daratumumab) as a monotherapy for high-risk smoldering multiple myeloma (SMM).
The applications are based on positive phase 3 AQUILA trial results, which showed significant improvement in progression-free survival (PFS) with SC Darzalex compared to active monitoring.

Johnson & Johnson Seeks FDA Approval for Daratumumab in High-Risk Smoldering Multiple Myeloma

Johnson & Johnson has submitted an application to the FDA for daratumumab as a subcutaneous monotherapy for high-risk smoldering multiple myeloma (SMM).
The application is supported by data from the phase 3 AQUILA study, which evaluated daratumumab's efficacy in prolonging progression-free survival in SMM patients.

Johnson & Johnson Seeks Approval for Darzalex in High-Risk Smoldering Multiple Myeloma

Johnson & Johnson has submitted applications to the FDA and EMA for Darzalex Faspro to treat high-risk smoldering multiple myeloma.
The applications are based on Phase 3 AQUILA study data, which evaluated Darzalex Faspro as a monotherapy in adult patients.

Darzalex Shows Promise in Smoldering Myeloma, Awaiting Regulatory Decision

Johnson & Johnson's Darzalex Faspro significantly improved progression-free survival in high-risk smoldering multiple myeloma patients compared to active monitoring.
The AQUILA phase 3 trial demonstrated a 51% reduction in disease progression or death with Darzalex, potentially setting a new treatment paradigm.

Johnson & Johnson Seeks Approval for Darzalex Faspro in the U.S. and Darzalex in the EU for Myeloma Treatment

Johnson & Johnson has submitted regulatory applications to the FDA for Darzalex Faspro and to the EMA for Darzalex, targeting myeloma treatment.
The applications are based on Phase 3 AQUILA study data, evaluating Darzalex Faspro as a monotherapy for high-risk smoldering multiple myeloma.

Johnson & Johnson Seeks Approval for Darzalex Faspro in Smoldering Multiple Myeloma

Johnson & Johnson has submitted applications to the FDA and EMA for Darzalex Faspro to treat high-risk smoldering multiple myeloma.
The applications are based on the Phase 3 AQUILA study, which evaluated Darzalex Faspro versus active monitoring in patients with the condition.

European Commission Approves Darzalex SC with VRd for Newly Diagnosed Multiple Myeloma

The European Commission has approved Darzalex subcutaneous formulation (SC) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) patients eligible for autologous stem cell transplant (ASCT).
The approval is based on the Phase 3 PERSEUS study, which demonstrated a 58% reduction in the risk of disease progression or death compared to VRd alone.

CHMP Recommends Daratumumab-Based Quadruplet Regimen for Newly Diagnosed Multiple Myeloma

The CHMP has recommended daratumumab subcutaneous formulation in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for transplant-eligible multiple myeloma patients.
The recommendation is based on the Phase 3 PERSEUS study, which demonstrated a 60% reduction in disease progression or death risk with the D-VRd regimen.

FDA Approves Darzalex Faspro Quadruplet Regimen for Transplant-Eligible Multiple Myeloma

The FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant.
The approval was based on the Phase 3 PERSEUS study, which demonstrated a 60% reduction in the risk of disease progression or death with the D-VRd regimen compared to VRd alone.

Reference News

[1]
J&J's Darzalex regimen approved by EC for newly diagnosed multiple myeloma - PMLiVE
pmlive.com · Oct 28, 2024

J&J's subcutaneous Darzalex approved by EC for NDMM in combination with VRd for ASCT-eligible patients, reducing disease...

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