Johnson & Johnson submits application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in combination with DARZALEX® (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma

Core Insights - Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) for an indication extension of TECVAYLI® (teclistamab) in combination with DARZALEX® (daratumumab SC) for treating adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy [1][2] Group 1: Clinical Study and Results - The application is supported by data from the Phase 3 MajesTEC-3 study, which showed a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared to standard treatment [1][2] - The MajesTEC-3 study enrolled 587 patients and demonstrated an 83.4% reduction in the risk of disease progression or death compared to standard regimens at nearly three years follow-up (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; P<0.0001) [2][4] - More than 90% of patients who remained progression-free at six months continued to be progression-free at three years [2] Group 2: Treatment Efficacy and Safety - Teclistamab and daratumumab SC work in a complementary manner by targeting both BCMA and CD38, enhancing immune-mediated responses earlier in treatment [2] - The combination regimen showed similar rates of Grade 3/4 treatment-emergent adverse events (TEAE) compared to standard care (95.1% vs. 96.6%) [2] - The most common Grade 3/4 events were cytopenia and infection, with infections observed in 96.5% of patients receiving teclistamab and daratumumab SC [2] Group 3: Regulatory and Market Position - The FDA has granted Breakthrough Therapy Designation for the teclistamab and daratumumab SC combination, expediting its development and regulatory review [2] - Johnson & Johnson aims to redefine treatment possibilities in multiple myeloma by using the right medicines early and combining them for optimal outcomes [3] Group 4: Background on Multiple Myeloma - Multiple myeloma is an incurable blood cancer affecting plasma cells, with over 35,000 new diagnoses in the EU in 2022 [8] - Patients experience frequent relapses, and remissions become progressively shorter with each line of therapy [8]