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The European Commission approves teclistamab monotherapy for R/R multiple myeloma from first relapse

On 23 October, 2026, the European Commission (EC) approved an indication extension of teclistamab as a monotherapy for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma who have received at least one prior line of therapy.1

Immunotherapies have transformed the treatment landscape of multiple myeloma, and trials are now evaluating the efficacy and safety of these therapies in earlier relapse.2 Teclistamab is a BCMAxCD3 targeting bispecific antibody, administered subcutaneously and has previously been approved by the EC for patients with R/R multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.1 In August 2026, the EC also approved teclistamab in combination with daratumumab for patients with R/R multiple myeloma as early as second line.3 Following this, the current approval of teclistamab monotherapy provides patients in Europe with R/R multiple myeloma an additional off-the-shelf second-line treatment option.1 The updated label also introduces a simplified dosing schedule, with monthly dosing from month 7 onwards, or from month 3 in eligible patients.1

This approval is supported by data from the ongoing, randomized Phase III MajesTEC-9 study (NCT05572515), which is evaluating the efficacy and safety of teclistamab monotherapy compared with pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with R/R multiple myeloma who have received one to three prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide.1,4 A total of 296 patients were randomly assigned to receive teclistamab and 297 to PVd or Kd.4

At the interim analysis (median follow-up, 17.3 months), the trial met its primary endpoint of progression free survival (PFS), as assessed by an independent review committee, with an estimated 18-month PFS rate of 69.8% with teclistamab versus 26.9% with PVd or Kd (hazard ratio [HR] for disease progression or death: 0.29; 95% CI: 0.23-0.38; p<0.001).4 Overall survival (OS) was also improved, with an estimated 18-month OS rate of 79.2% with teclistamab versus 68.6% with PVd or Kd (HR for death: 0.60; 95% CI: 0.43-0.83; p=0.002).4 Furthermore, all key secondary endpoints were met, with a significantly higher proportion of patients achieving a complete response or better with teclistamab compared with PVd or Kd (65.9% vs. 16.8%, p<0.001).1,4

Teclistamab’s safety profile was consistent with previously observed data.1,4 Key safety findings (teclistamab versus PVd or Kd) include:

  • Median treatment duration: 13.1 vs. 7.0 months1
  • Overall adverse events (AEs): 99.7% vs. 97.9%1
  • Grade 3/4 AEs: 84.9% vs. 76.3%
  • Grade 5 AEs: 6.5% vs. 3.5%
  • Grade 3/4 infections: 41.6% vs. 29.0%4
  • Cytokine release syndrome (teclistamab arm): 66.0%, mostly grade 1 or 24
  • Immune effector cell-associated neurotoxicity syndrome (teclistamab arm): 4.1%4

To conclude, this approval contributes to the changing treatment paradigm of multiple myeloma in Europe, introducing an additional immunotherapy in the earlier relapse setting.1 With teclistamab now available as a monotherapy as soon as first relapse, alongside its combination with daratumumab, clinicians now have another convenient, off-the-shelf option to tailor treatment for patients with R/R multiple myeloma.1

References

  1. Johnson & Johnson. European Commission approves Johnson & Johnson’s TECVAYLI®▼ (teclistamab) monotherapy for relapsed/refractory multiple myeloma, expanding treatment options from first relapse. Available here. (Last accessed 05/11/26)
  2. Biltibo EMD, Surapaneni M, Al Hadidi S, et al. Current and Future Directions of Immunotherapies in Multiple Myeloma.  Am Soc Clin Oncol Educ Book. 2025 Jun; 45(3): e473316.
  3. Johnson & Johnson. European Commission approves Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma, offering a potential new standard of care. Available here. (Last accessed 05/11/26)
  4. Touzeau C, Mina R, Quach H, et al. Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy. N Engl J Med. 2026;395(5):440-453.

Written by Clare Harris

Edited by Natalie Markova