BEERSE, BELGIUM, March 10, 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) as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy.
Bringing new hope to a high unmet need population
Despite major advances in frontline multiple myeloma treatment, including anti-CD38-based quadruplet regimens, most patients will ultimately relapse.2 Outcomes are particularly poor once patients become refractory to key backbone therapies such as anti‑CD38 monoclonal antibodies and lenalidomide.2,3 This patient population has historically faced limited choices and challenging second-line treatment pathways, reinforcing the need for additional effective immunotherapy options that can be given across practice settings.3
“A significant number of patients with multiple myeloma continue to relapse and become refractory to currently available therapies, representing one of the largest and most challenging unmet needs in the disease,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “Making teclistamab monotherapy available to patients as early as second line, where it has the potential to meaningfully improve long-term outcomes and change the course of the disease, could bring new hope to patients and their families.”
MajesTEC-9 study results
The submission is supported by data from the Phase 3 MajesTEC-9 trial evaluating the efficacy and safety of teclistamab versus the standard of care of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in 614 patients with RRMM.1 Results show teclistamab delivers superior progression-free survival (PFS) and overall survival (OS) versus standard of care as early as second line, including a 71% reduction in the risk of disease progression or death (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38) and a 40% reduction in the risk of death (HR, 0.60; 95% CI, 0.43-0.83) in a patient population that was predominantly refractory to anti-CD38 monoclonal antibodies and lenalidomide.2
The safety profile of teclistamab monotherapy was clinically manageable and consistent with its known profile, with no new safety signals identified.2 Infections can be managed with robust infection management protocols, which include patient monitoring, immunoglobulin therapy and antimicrobial prophylaxis.4
The Independent Data Monitoring Committee recommended unblinding the study based on the strength of the data in the first pre-specified interim analysis.2 This submission represents the first of several planned global regulatory filings, with full results to be presented at a future major medical meeting.
“At Johnson & Johnson, we are driven by a clear purpose to deliver innovations that redefine expectations of what a multiple myeloma diagnosis means to patients, at every stage of the disease,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson. “With today’s regulatory milestone for teclistamab, we are advancing a widely available immunotherapy approach with the potential to support deep and sustained responses over time.”
About the MajesTEC-9 study
MajesTEC-9 (NCT05572515) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab as a monotherapy versus pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide.1 The majority of patients enrolled were refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%) and more than 90% were refractory to their last line of therapy.2 The primary endpoints are progression-free survival (PFS) and the number of participants reporting cytokine release syndrome (CRS) cases by severity.1 Secondary endpoints include complete response or better (≥CR); duration of response (DOR); time to next treatment (TTNT); progression-free survival on next-line therapy (PFS2); overall survival (OS); number of participants with adverse events (AEs) and serious adverse events (SAEs) by severity; change from baseline in symptoms, functioning and overall health-related quality of life (HRQoL) as assessed by the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30); and time to worsening in symptoms, functioning and overall HRQoL.1 The MajesTEC-9 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen.1
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.4,7 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.4,8,9,10,11
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.6
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.12,13 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.12,13 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.14 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.15,16,17 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.18
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.
References
[1] ClinicalTrials.gov. A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-9). Available at: https://clinicaltrials.gov/study/NCT05572515. Last accessed: March 2026.
[2] Johnson & Johnson.com. TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide. Available at: https://www.jnj.com/media-center/press-releases/tecvayli-monotherapy-demonstrates-superior-progression-free-and-overall-survival-versus-standard-of-care-as-early-as-first-relapse-in-patients-with-multiple-myeloma-predominantly-refractory-to-anti-cd38-therapy-and-lenalidomide. Last accessed: March 2026.
[3] Ramasamy K, et. al. Real-World Treatment Patterns and Clinical Outcomes in Patients With Multiple Myeloma Previously Treated With Lenalidomide and an Anti-CD38 Monoclonal Antibody. Clin Lymphoma Myeloma Leuk. 2025 May;25(5):337-348.e2.
[4] European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf. Last accessed: March 2026.
[5] Johnson & Johnson.com. Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma. Available at: https://innovativemedicine.jnj.com/emea/janssen-marks-first-approval-worldwide-tecvaylirvteclistamab-ec-authorisation-first-class-bispecific. Last accessed: March 2026.
[6] Johnson & Johnson.com. European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: https://www.jnj.com/media-center/press-releases/european-commission-approves-reduced-dosing-frequency-for-janssens-bispecific-antibody-tecvayli-teclistamab. Last accessed: March 2026.
[7] Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. New England Journal of Medicine. 2022;287(6):494-505.
[8] 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: March 2026.
[9] ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: https://clinicaltrials.gov/ct2/show/NCT04722146. Last accessed: March 2026.
[10] ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT04586426. Last accessed: March 2026.
[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: March 2026.
[12] Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207.
[13] American Society of Clinical Oncology. Multiple Myeloma: Introduction. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/if-you-have-multiple-myeloma. Last accessed: March 2026.
[14] 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: March 2026.
[15] Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347.
[16] Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23.
[17] Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430.
[18] American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Last accessed: March 2026.
Media Contact
Jenni Mildon
+44 7920 418 552
Investor Contact
Jessica Margevich