Core Insights - The FDA Oncologic Drugs Advisory Committee (ODAC) voted 6-2 in favor of the benefit-risk profile of DARZALEX FASPRO® for treating high-risk smoldering multiple myeloma (HR-SMM), marking a significant step in the treatment landscape for this condition [1][2][3] Company Insights - Johnson & Johnson aims to transform oncology care by advocating for early intervention in high-risk smoldering multiple myeloma, potentially delaying or preventing progression to active multiple myeloma [4][6] - The company emphasizes its commitment to evolving treatment paradigms for multiple myeloma, aligning with its vision for a future where early diagnosis and treatment are standard [4][5] Industry Insights - Currently, there are no approved treatments specifically for HR-SMM, with an estimated 35,000 new multiple myeloma cases expected in the U.S. in 2024, of which approximately 15% are classified as smoldering [3][7] - The standard of care for smoldering multiple myeloma is active monitoring, which may delay therapeutic intervention until significant disease progression occurs [3][8] - The AQUILA study, a Phase 3 trial, demonstrated that early intervention with DARZALEX FASPRO® could reduce the risk of progression or death in patients with HR-SMM [4][6]

Approval cements daratumumab as a foundational therapy in newly diagnosed multiple myeloma and the only anti-CD38 antibody for all patient types in this setting  Phase 3 CEPHEUS study shows significant improvement in minimal residual disease (MRD)-negativity rate, progression-free survival and complete response or better versus standard of care1 Beerse, Belgium, April 07, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) ...

Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of daratumumab subcutaneous (SC) formulation for newly diagnosed multiple myeloma (NDMM), which would make it the only anti-CD38 therapy available for all patient types in the frontline setting [1][2][5]. Group 1: Company Developments - Janssen-Cilag International NV, a Johnson & Johnson company, announced the CHMP's positive recommendation for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone for adult patients with NDMM [1][5]. - The recommendation is based on the results from the Phase 3 CEPHEUS study, which demonstrated improved progression-free survival for patients receiving daratumumab-VRd compared to standard VRd [1][2][5]. - Daratumumab has been a foundational therapy in multiple myeloma treatment, with over 618,000 patients treated globally since its launch [5][6]. Group 2: Study Insights - The CEPHEUS study (NCT03652064) is an international, randomized, open-label Phase 3 trial that enrolled 395 patients with NDMM who were ineligible for stem cell transplantation [2][5]. - The primary endpoint of the study was the overall Minimal Residual Disease (MRD) negativity rate, with a median patient age of 70 years [2][5]. - Results from the CEPHEUS study were presented at the 2024 International Myeloma Society Annual Meeting and the 2024 American Society of Hematology Annual Meeting [1][2]. Group 3: Product Information - Daratumumab is the only CD38-directed antibody approved for subcutaneous administration in multiple myeloma treatment [5][6]. - The drug works by binding to CD38, a surface protein present on myeloma cells, inhibiting tumor cell growth and causing myeloma cell death [5][6]. - Data from ten Phase 3 clinical trials have shown significant improvements in progression-free survival and/or overall survival with daratumumab-based regimens [5][6].