HORSHAM, Pennsylvania – March 5, 2026
Johnson & Johnson announced that the U.S. Food and Drug Administration has approved the combination therapy TECVAYLI (teclistamab-cqyv) and DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adults with Relapsed/Refractory Multiple Myeloma who have received at least one prior line of therapy. The approval introduces a potential new standard of care as early as second-line treatment, offering a powerful immunotherapy-based regimen designed to activate the immune system against cancer cells. Based on robust Phase 3 clinical trial results, the therapy demonstrated significant improvements in progression-free survival and overall survival compared with existing treatment options, representing an important advancement for patients facing disease relapse.
Breakthrough Phase 3 Results Demonstrate Significant Survival Benefit
The approval was supported by results from the MajesTEC-3 Phase 3 randomized clinical study, which evaluated the safety and effectiveness of teclistamab combined with daratumumab versus standard regimens including daratumumab, dexamethasone, pomalidomide, or bortezomib in patients with previously treated multiple myeloma. Findings showed an 83% reduction in the risk of disease progression or death compared with current standard-of-care therapies. After a median follow-up of three years, the progression-free survival rate reached 83% in the Tecvayli plus Darzalex Faspro group compared with 30% in the control arm, highlighting a durable and clinically meaningful benefit. Overall survival outcomes also favored the combination therapy, with 83.3% of patients alive at three years compared with 65% in the control group. Additional secondary endpoints demonstrated strong improvements across treatment response metrics, including higher overall response rates, increased complete response rates, and significantly higher minimal residual disease negativity, further reinforcing the therapy’s effectiveness in controlling disease progression.
Innovative Immune-Based Mechanism Targets Myeloma Cells
The newly approved combination therapy leverages a novel immune-engaging mechanism designed to target cancer cells expressing B-cell maturation antigen (BCMA). Tecvayli is a first-in-class bispecific T-cell engager antibody that simultaneously binds to the CD3 receptor on T cells and BCMA on myeloma cells, enabling the immune system to directly attack malignant plasma cells. Darzalex Faspro, a subcutaneous CD38-directed monoclonal antibody therapy, complements this activity by further enhancing immune-mediated tumor destruction. Together, the two therapies work synergistically to prime and activate the immune response against multiple myeloma, potentially improving treatment outcomes for patients experiencing relapse after initial therapy. Experts note that earlier introduction of effective immunotherapies could help overcome the challenge of repeated relapse and declining responsiveness to treatment commonly seen in advanced stages of the disease.
Advertisement
Expanding Treatment Options for Patients With Multiple Myeloma
Multiple myeloma remains one of the most common blood cancers worldwide and is currently considered incurable despite significant therapeutic progress in recent decades. In the United States alone, more than 35,000 people are diagnosed with multiple myeloma annually, and relapse remains common for many patients following initial therapy. Johnson & Johnson highlighted that the approval of Tecvayli plus Darzalex Faspro represents a major milestone in the company’s ongoing effort to transform outcomes for people living with this disease. The combination therapy adds a powerful new option to the company’s expanding multiple myeloma portfolio and reflects broader industry efforts to develop innovative immunotherapies capable of delivering longer-lasting disease control. Since its initial approval in 2022, Tecvayli has already been used in the treatment of more than 23,000 patients globally, and the newly approved combination regimen is expected to further expand access to advanced immune-targeted therapies across oncology care settings.
With compelling clinical evidence supporting improved survival outcomes and a manageable safety profile, the approval of Tecvayli plus Darzalex Faspro marks a significant step forward in the evolving treatment landscape for relapsed or refractory multiple myeloma. Researchers and clinicians believe the regimen may help redefine treatment strategies by enabling earlier use of highly effective immunotherapies, potentially improving long-term outcomes for patients living with this challenging blood cancer.
z
Source: Johnson & Johnson press release
