CHMP recommends approval of Johnson & Johnson’s TECVAYLI®▼ (teclistamab) in relapsed/refractory multiple myeloma after at least one prior therapy

• CHMP recommendation follows positive Phase 3 study results, marking the second Phase 3 study to demonstrate benefit with a TECVAYLI^®-based regimen in the second-line setting^1,2
• Results demonstrated significantly improved progression-free and overall survival versus standard of care, reinforcing TECVAYLI^®’s potential for patients with relapsed/refractory multiple myeloma (RRMM)¹

BEERSE, BELGIUM, Sept. 18, 2026 (ZM NEWSWIRE) — Johnson & Johnson, a worldwide leader in multiple myeloma, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of TECVAYLI^® (teclistamab) for the treatment of adult patients with RRMM who have received at least one prior therapy.

Addressing evolving treatment needs in relapsed or refractory multiple myeloma
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 such as anti-CD38 monoclonal antibodies and lenalidomide.^3,4 Despite recent advances, there remains a critical need for additional effective immunotherapy options, particularly in earlier lines of therapy.^3,4

Expert and company perspectives support teclistamab use earlier in the treatment pathway
“Relapsed or refractory multiple myeloma remains a complex disease, with diverse and evolving patient needs,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “This positive CHMP opinion reflects the importance of teclistamab in multiple myeloma and further reinforces its potential as a foundational immunotherapy after first-line treatment. By providing steroid-sparing combination and monotherapy regimens, teclistamab has the potential to expand the choices for patients living with the disease and redefine what’s possible in multiple myeloma.”

“Today’s recommendation reflects our longstanding commitment to transforming outcomes for patients with multiple myeloma by advancing innovative therapies, such as teclistamab, into earlier lines of treatment, where they have the greatest potential to change the trajectory of the disease,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “By investing across the treatment continuum, from established foundations of care to novel immunotherapies, we remain focused on delivering differentiated treatment options that address patients’ diverse needs at every stage of their disease, all with the goal of improving long-term outcomes and, where possible, moving people closer to durable remission and, ultimately, cure.”

Teclistamab monotherapy demonstrated significant improvements in progression-free and overall survival compared to standard of care
The CHMP recommendation 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 to 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.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

This regulatory milestone builds on the recent European Commission approval of teclistamab in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, based on the results of the MajesTEC-3 study published in The New England Journal of Medicine.⁷ Together, these two Phase 3 studies help establish the potential of teclistamab-based regimens as an important treatment option across a broad second-line population.⁷

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.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.⁸ In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.⁹ 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.⁷

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.^6,10 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 Teclistamab is currently being evaluated in several combination studies.^11,12,13,14

To date, more than 30,700 patients have been treated worldwide with teclistamab.¹⁵

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.^16,17 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.^18,19 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.²⁰ Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.^21,22,23 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.²⁴

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 http://www.sec.gov/, http://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
• Teclistamab monotherapy
• 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
• BCMA-targeted bispecific therapy
• EMEA haematology pipeline
• Multiple myeloma innovation
• Multiple myeloma treatment

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 Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2025;394(8):739-752.
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: September 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: September 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: September 2026.
⁷ 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: https://www.jnj.com/innovativemedicine/emea/media-center/press-releases/european-commission-approves-johnson-johnsons-tecvayli-teclistamab-plus-daratumumab-for-relapsed-refractory-multiple-myeloma-offering-a-potential-new-standard-of-care. Last accessed: September 2026.
⁸ 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: September 2026.
⁹ 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: September 2026.
¹⁰ Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;387(6):494-505.
¹¹ 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: September 2026.
¹² 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: September 2026.
¹³ 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: September 2026.
¹⁴ 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: September 2026.
¹⁵ J&J Data on File. Number of Patients Treated with TECVAYLI Worldwide as of July 2026.
¹⁶ Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207.
¹⁷ Myeloma UK. What is myeloma? Available at: https://www.myeloma.org.uk/understanding-myeloma/what-is-myeloma/. Last accessed: September 2026.
¹⁸ Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668.
¹⁹ Mayo Clinic. Multiple Myeloma. Available at: https://www.mayoclinic.org/diseases-conditions/multiple-myeloma/symptoms-causes/syc-20353378. Last accessed: September 2026.
²⁰ 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/data-explorer#/historical/incidence-mortality-by-registry?sex=0&ageFrom=0&ageTo=85%2B&indicator=IN&cancerEntity=85&registry=-1&statistic=ASR_EU_NEW&yearFrom=2010&yearTo=2023. Last accessed: September 2026.
²¹ 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.
²² 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.
²³ McCurdy A, et al. Redefining attrition in multiple myeloma (MM): a Canadian myeloma research group (CMRG) analysis. Blood Cancer Journal. 2023;13(1):111.
²⁴ 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: September 2026.

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