J&J Pushes Forward With EMA Approval Bid For Dual Antibody Combo Against Relapsed Myeloma

Johnson & Johnson (JNJ) is seeking the green light from European regulators for an immunotherapy combination targeting a stubborn blood cancer. The company has filed a Type II variation application with the European Medicines Agency (EMA) requesting authorization for TECVAYLI combined with DARZALEX subcutaneous injection—a one-two punch designed to help patients with relapsed or refractory multiple myeloma who’ve already undergone at least one previous treatment course.

The Science Behind The Combo

Multiple myeloma remains a relentless foe in oncology. This blood cancer forces malignant plasma cells to crowd the bone marrow, displacing healthy cells and triggering a cascade of complications: bone erosion, anemia, recurrent infections, and kidney dysfunction. The defining challenge is that patients face repeated cycles of remission and relapse, with each recovery becoming harder to achieve.

TECVAYLI (teclistamab), an off-the-shelf bispecific antibody, functions as an immune redirector—it trains T-cells to seek out and destroy myeloma cells expressing BCMA. DARZALEX (daratumumab), a CD38-targeted monoclonal antibody co-discovered by Genmab and now globally marketed by J&J, amplifies this attack. The pairing is engineered to mobilize immune-mediated tumor killing earlier in the therapeutic sequence, potentially reshaping treatment trajectories.

Phase 3 Data Provides Strong Backing

The EMA nod ambitions rest on Phase 3 MajesTEC-3 trial results. This study tracked 587 patients comparing TECVAYLI plus DARZALEX against conventional regimens combining daratumumab with dexamethasone plus either pomalidomide or bortezomib. The outcome: an impressive 83.4% reduction in progression or death risk at nearly three years of monitoring. Beyond raw numbers, persistence mattered—over 90% of patients maintaining disease control at six months sustained that advantage through the three-year mark.

Tolerability aligned with each drug’s known safety profile, with cytopenias and infection as the primary Grade 3/4 concerns. The Independent Data Monitoring Committee deemed the evidence sufficiently compelling to unblind the trial early.

Regulatory Momentum Building

These findings earned fresh-breaking presentation status at the 2025 ASH Annual Meeting and simultaneous publication in The New England Journal of Medicine. Stateside, J&J has also submitted a supplemental Biologics License Application to the U.S. FDA, which has awarded the TECVAYLI-DARZALEX pairing Breakthrough Therapy Designation—a fast-track credential acknowledging the combination’s potential to address an unmet serious condition.

“We’re committed to reimagining what’s achievable in multiple myeloma,” noted Jordan Schecter, M.D., Vice President and Disease Area Leader for Multiple Myeloma at J&J Innovative Medicine. “Our strategy centers on deploying the most effective medicines early and leveraging combinations and sequencing to optimize patient outcomes.”

Stock Movement

JNJ shares have fluctuated between $140.68 and $215.19 over the past year. Currently trading at $204.24, the stock is down 0.04%.