On October 23, 2026 Johnson & Johnson, a worldwide leader in multiple myeloma, reported 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
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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: View Source
▼ 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.
(Press release, Johnson & Johnson, OCT 23, 2026, View Source [SID1234673764])