globenewswire news

• Approval is based on Phase 3 results demonstrating significant progression-free and overall survival benefits, with teclistamab reducing risk of disease progression or death by 71% and risk of death by 40%, compared with the standard of care¹
  
• Further expands treatment options for relapsed/refractory multiple myeloma, making teclistamab available in the second line setting through both combination and monotherapy approaches^1,2

BEERSE, BELGIUM, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson, a worldwide leader in multiple myeloma, today announced that the European Commission (EC) has approved an indication extension of TECVAYLI^® (teclistamab) for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. Building on the recent EC approval of teclistamab plus daratumumab, this indication extension introduces teclistamab monotherapy as an additional second-line treatment option for patients living with RRMM and reinforces the wider potential of teclistamab across both monotherapy and combination approaches for patients at first relapse.^1,2

Building momentum for teclistamab-based regimens at first relapse
Many patients with multiple myeloma relapse after first-line therapy, and treatment options are increasingly limited once the disease becomes refractory to established treatment classes.^3,4 Despite recent advances, there remains a critical need for additional effective immunotherapy options at first relapse, where treatment decisions can have a meaningful impact on long-term outcomes.^3,4

Expert and company perspectives on expanding treatment options with teclistamab
“Patients with relapsed or refractory multiple myeloma often experience shorter remissions and diminishing responses with each subsequent line of therapy, making effective treatment at first relapse increasingly important,” said Cyrille Touzeau, M.D., Ph.D., Professor, University Hospital of Nantes.* “The approval of teclistamab monotherapy gives physicians an additional immunotherapy option in the second-line setting, supported by significant improvements in both progression-free and overall survival. With nearly two-thirds of patients achieving a complete response or better, the results seen with teclistamab are encouraging and demonstrate the depth of response achieved in the study.”

“Building on the recent approval of teclistamab plus daratumumab, this European Commission further reinforces the strength of bispecific-based immunotherapy approaches as early as second line,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “Together, the MajesTEC-3 and MajesTEC-9 studies support the potential of teclistamab-based therapies to advance the treatment paradigm and improve outcomes for patients earlier in their disease journey.”

“Today's approval marks another important step in our ambition to bring innovative immunotherapies earlier in the treatment journey for patients with multiple myeloma,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “With positive Phase 3 results from both MajesTEC-3 and MajesTEC-9, we continue to build evidence for teclistamab-based regimens across a broad second-line patient population. Together, these studies highlight the potential of teclistamab to become a foundational option at first relapse, while reinforcing our ambition to improve long-term outcomes for patients.”

Phase 3 monotherapy data demonstrated significant survival benefits compared with standard of care, supporting the use of teclistamab in second-line RRMM

The updated label will replace the current monotherapy indication and posology, and introduce a simplified dosing schedule with monthly dosing frequency from month 7 onwards. Eligible patients may also transition to monthly dosing as early as month 3, further optimising the dosing schedule and potentially reducing the treatment burden for patients.

The EC approval is supported by data from the Phase 3 MajesTEC-9 study (NCT05572515), evaluating the efficacy and safety of teclistamab, a bispecific T-cell engager, as a monotherapy versus pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM who have received one to three prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide.⁵

Significant improvements were observed in both progression-free survival (PFS) and overall survival (OS).¹ Treatment with teclistamab demonstrated a 71% reduction in the risk of disease progression or death (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38; p<0.001) and a 40% reduction in the risk of death (HR, 0.60; 95% CI, 0.43-0.83; p = 0.002) compared with the standard of care.¹ Teclistamab’s 18-month PFS rate was 69.8% versus 26.9% for the standard of care, and the 18-month OS rate was 79.2% with teclistamab versus 68.6% for the standard of care.¹ Additionally, all key secondary endpoints showed significant improvement with teclistamab versus standard of care, including nearly two-thirds of patients achieving a complete response or better (≥CR; 65.9% vs. 16.8%; p<0.001).¹

Safety profile consistent with that established in prior studies

The safety profile for teclistamab in the study was consistent with its known safety profile.^1,6 The median duration of treatment on teclistamab was almost two times longer than standard of care (13.1 months vs. 7.0 months), with similar rates of adverse events (AEs) observed between teclistamab and standard of care (99.7% vs. 97.9%).¹ Grade 3/4 AEs occurred in 84.9% of teclistamab recipients versus 76.3% of PVd or Kd recipients, while Grade 5 AEs occurred in 6.5% versus 3.5%, respectively.¹ Infections were more frequent with teclistamab than with standard of care (Grade 3/4, 41.6% vs. 29.0%), and rates of Grade 3 or higher infections decreased over time.¹

About the MajesTEC-9 study

MajesTEC-9 (NCT05572515) is an ongoing, randomised Phase 3 study comparing teclistamab monotherapy with 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 including lenalidomide and an anti-CD38 monoclonal antibody.⁵ The primary endpoint is progression-free survival (PFS); secondary endpoints include complete response or better (≥CR), duration of response (DoR), overall survival (OS), safety and patient-reported outcomes.⁵

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.⁷ In August 2026, the EC also approved a Type II variation application for teclistamab in combination with daratumumab as early as second line for RRMM.²

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody. Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer.^6,8 Teclistamab is currently being evaluated in several combination studies.^9,10,11,12
 
To date, more than 30,700 patients have been treated worldwide with teclistamab.¹³

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 a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.^14,15 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.^16,17 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died.¹⁸ Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.¹⁹ 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.²⁰

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 https://www.jnj.com/innovativemedicine/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 www.sec.gov, www.jnj.com, www.investor.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-9 Phase 3 clinical trial
• TECVAYLI
• Teclistamab
• 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
• EMEA haematology pipeline
• Multiple myeloma innovation
• Multiple myeloma treatment
  
  

*Cyrille Touzeau, M.D., Ph.D., Professor, University Hospital of Nantes, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

CP-606702

October 2026

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References: 

¹ Touzeau C, et al. Teclistamab monotherapy in multiple myeloma with 1–3 prior lines of therapy. N Engl J Med. 2026;395(5):440-453.
² Johnson & Johnson.com. European Commission approves Johnson & Johnson’s TECVAYLI^®▼ (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma, offering a potential new standard of care. Available at: European Commission approves Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma, offering a potential new standard of care. Last accessed: October 2026.
³ 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: October 2026.
⁴ 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.
⁵ 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: October 2026.
⁶ 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: October 2026. 
⁷ 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://www.jnj.com/media-center/press-releases/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. Last accessed: October 2026.
⁸ Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;387(6):494-505.
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: October 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: October 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: October 2026.
¹² 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: October 2026.
¹³ J&J Data on File. Number of Patients Treated with TECVAYLI Worldwide as of July 2026. 
¹⁴ Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207.
¹⁵ Myeloma UK. What is myeloma? Available at: https://www.myeloma.org.uk/understanding-myeloma/what-is-myeloma/. Last accessed: October 2026.
¹⁶ Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668.
¹⁷ Mayo Clinic. Multiple Myeloma. Available at: https://www.mayoclinic.org/diseases-conditions/multiple-myeloma/symptoms-causes/syc-20353378. Last accessed: October 2026.
¹⁸ ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2024, by Country. Multiple Myeloma. Available at: https://ecis.jrc.ec.europa.eu/data-explorer#/estimates/estimated-incidence-mortality-by-cancer-summary?indicator=IN&sex=0&ageFrom=0&ageTo=85%2B&cancerEntity=-1&yearFrom=2024&yearTo=2024&country=EU27X. Last accessed: October 2026.
¹⁹ 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. 
²⁰ 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: October 2026.

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