(RTTNews) - Johnson & Johnson (JNJ) has submitted a Type II variation application to the European Medicines Agency seeking approval for the use of TECVAYLI in combination with DARZALEX subcutaneous formulation for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy.
*Type II variation refers to a major change to a marketing authorisation that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration. (Source: EMA).
Multiple myeloma is an incurable blood cancer in which malignant plasma cells accumulate in the bone marrow, crowding out healthy cells and causing complications such as bone damage, anemia, infections, and kidney impairment.
Patients typically experience repeated relapses, with responses becoming shorter and more difficult to achieve over time.
TECVAYLI (teclistamab) is an off-the-shelf bispecific antibody that redirects T-cells to target BCMA-expressing myeloma cells, while DARZALEX (daratumumab), originally discovered by Genmab and commercialized globally by Johnson & Johnson is a CD38-directed antibody widely used across multiple myeloma treatment settings. Together, the combination is designed to activate and enhance immune-mediated tumor killing earlier in the treatment journey.
The EMA submission is supported by results from the Phase 3 MajesTEC-3 study, which enrolled 587 patients and compared TECVAYLI plus DARZALEX against standard regimens that included daratumumab with dexamethasone and either pomalidomide or bortezomib (DPd/ DVd).
The combination demonstrated a statistically significant improvement in progression-free and overall survival, reducing the risk of disease progression or death by 83.4% at nearly three years of follow-up.
More than 90% of patients who were progression-free at six months remained progression-free at three years, according to the company. Safety findings were consistent with known profiles of the individual agents, with Cytopenias and infection being the most common Grade 3/4 adverse events.
Based on the strength of the data, the Independent Data Monitoring Committee recommended unblinding the study. The results were recently presented as a late-breaking oral presentation at the 2025 ASH Annual Meeting and simultaneously published in The New England Journal of Medicine.
Johnson & Johnson has also submitted a supplemental Biologics License Application to the U.S. FDA, which has granted Breakthrough Therapy Designation for the TECVAYLI- DARZALEX combination.
"Johnson & Johnson is committed to redefining what's possible in multiple myeloma. An integral part of this strategy involves using the right medicines as early as possible and combining and sequencing them to achieve the best outcomes," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
JNJ has traded between $140.68 and $215.19 over the past year. The stock is currently trading at $204.24, down 0.04%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
