Novel immunotherapy combination regimen brings together two complementary therapies to improve outcomes for people living with multiple myeloma as early as second line1
The application is supported by data from the Phase 3 MajesTEC-3 study demonstrating a statistically significant improvement in progression-free and overall survival compared to standard treatment1
Beerse, Belgium, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI®▼(teclistamab) in combination with DARZALEX® subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy.
The combination of teclistamab and daratumumab SC work in a complementary manner by targeting both BCMA and CD38 to prime and activate the immune system, supporting the potential to improve patient outcomes by enhancing immune-mediated response earlier in the treatment journey.1
“There remains a critical need for off-the-shelf treatment options that can achieve deep and durable responses at second line, when immune function is better preserved,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson Innovative Medicine. “Teclistamab and daratumumab SC is the first off-the-shelf immunotherapy combination to demonstrate significant improvements in progression-free and overall survival in relapsed/refractory multiple myeloma as early as second-line treatment, compared to current standards of care.”
The submission is supported by data from the Phase 3 MajesTEC-3 study. The study enrolled 587 patients across two treatment arms: teclistamab and daratumumab SC versus daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd).1 Results show an 83.4 percent 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 percent confidence interval [CI], 0.12-0.23; P<0.0001).1,2 More than 90 percent of patients who remained progression-free at six months (n=249) remained progression-free at three years.1 In the study, teclistamab plus daratumumab SC and standard of care comparators had similar rates of Grade 3/4 treatment-emergent adverse events (TEAE) (95.1 percent vs. 96.6 percent).1 Most common Grade 3/4 events were cytopenia and infection.1 Infections were observed with teclistamab and daratumumab SC (any grade, 96.5 percent; Grade 3/4, 54.1 percent) and DPd/DVd comparator (any grade, 84.1 percent; Grade 3/4, 43.4 percent).1
Based on the statistical significance of the results, the Independent Data Monitoring Committee (IDMC) recommended unblinding of the study.3 Data from the MajesTEC-3 study were recently presented as a late-breaking oral presentation at the 2025 American Society of Hematology (ASH) Annual Meeting, with simultaneous publication in The New England Journal of Medicine.1,2 Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) for the use of teclistamab and daratumumab SC in combination as a treatment for RRMM to the U.S. Food and Drug Administration (FDA). The FDA has granted Breakthrough Therapy Designation for the combination regimen, which allows for expediting the development and regulatory review of a medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement over available therapies on a clinically significant endpoint(s).
“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. “Today’s submission to the EMA reinforces this approach. Daratumumab has become a cornerstone of care for patients with newly diagnosed multiple myeloma, and by combining it with teclistamab, we see the potential to advance outcomes for relapsed patients as early as second line.”
About the MajesTEC-3 Study
MajesTEC-3 (NCT05083169) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab subcutaneous (SC) and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy.1,4 The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety.4 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen.4
About Teclistamab
Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.5 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.6
Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.7,8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. Teclistamab is currently being evaluated in several combination studies.4,7,9,10,11
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf.▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring.7
About Daratumumab and Daratumumab SC
Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.
In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 618,000 patients worldwide.12 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.13 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.13
CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.13 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.13 Daratumumab may also have an effect on normal cells.13 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.14,15,16,17,18,19,20,21,22,23
For further information on daratumumab, please see the Summary of Product Characteristics at:
https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf
About Multiple Myeloma
Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.24,25 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.24,25 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.26 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.27,28,29 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.30
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at www.innovativemedicine.jnj.com/emea. Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov/, http://www.jnj.com/ or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Key Search Terms
- MajesTEC-3 Phase 3 clinical trial
- TECVAYLI
- Teclistamab
- DARZALEX
- Daratumumab
- Teclistamab and daratumumab combination
- TECVAYLI and DARZALEX combination
- Relapsed and or refractory multiple myeloma (RRMM)
- Early relapse multiple myeloma
- Second-line multiple myeloma treatment
- First relapse therapy for multiple myeloma
- Treatment resistance in multiple myeloma
- Progression-free survival (PFS) in multiple myeloma
- Overall survival (OS) in multiple myeloma
- Multiple myeloma
- Bispecific antibody therapy
- CD38-targeted therapy
- BCMA-targeted bispecific therapy
- Combination immunotherapy
- EMEA haematology pipeline
- Multiple myeloma innovation
- Multiple myeloma treatment
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[2] Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. The New England Journal of Medicine. 2025; Full article and supplementary material. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2514663. Last accessed: January 2026.
[3] Johnson&Johnson.com. TECVAYLI® plus DARZALEX FASPRO® combination regimen significantly improves progression-free survival and overall survival versus standard of care. Available at: https://www.jnj.com/media-center/press-releases/tecvayli-plus-darzalex-faspro-combination-regimen-significantly-improves-progression-free-survival-and-overall-survival-versus-standard-of-care. Last accessed: January 2026.
[4] ClinicalTrials.gov. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: https://clinicaltrials.gov/study/NCT05083169. Last accessed: January 2026.
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[11] ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT04108195. Last accessed: January 2026.
[12] J&J Data on File (RF-452129). Number of Patients Treated with DARZALEX Worldwide as of December 2024.
[13] Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: http://www.businesswire.com/news/home/20200604005487/en/European-Commission-GrantsMarketingAuthorisation-for-DARZALEX%C2%AE%E2%96%BC-daratumumab-SubcutaneousFormulation-for-all-CurrentlyApproved-Daratumumab-Intravenous-Formulation-Indications. Last accessed: January 2026.
[14] Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38.
[15] Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. New England Journal of Medicine. 2019;380(22):2104-2115.
[16] Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395(10218):132-141.
[17] Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812.
[18] Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood. 2020;2;136(1):71-80.
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[21] Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518.
[22] Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024.
[23] Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. New England Journal of Medicine. 2024; 390(4):301-313.
[24] Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207.
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[26] ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: https://ecis.jrc.ec.europa.eu/explorer.php?$0-0$1-All$2-All$4-1,2$3-51$6-0,85$5-2022,2022$7-7$CEstByCountry$X0_8-3$X0_19-AE27$X0_20-No$CEstBySexByCountry$X1_8-3$X1_19-AE27$X1_-1-1$CEstByIndiByCountry$X2_8-3$X2_19-AE27$X2_20-No$CEstRelative$X3_8-3$X3_9-AE27$X3_19-AE27$CEstByCountryTable$X4_19-AE27. Last accessed: January 2026.
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CP-553511
December 2025
CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Lauren Johnson investor-relations@its.jnj.com
