Teclistamab receives EMA approval for adult patients with relapsed/refractory (R/R) multiple myeloma

On August 24 2022, the European Medicines Agency (EMA) approved the use of teclistamab for the treatment of patients with relapsed/refractory (R/R) multiple myeloma who have received at least three prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.1

While novel agents and combination therapies have greatly transformed the treatment landscape of multiple myeloma, relapse is still common and this disease remains largely incurable.2 Therefore, there is a need to continue exploring novel targets and provide patients with more therapeutic options.

Teclistamab is a T-cell redirecting bispecific antibody that targets both CD3 expressed on T-cells and BCMA expressed on myeloma cells, and has shown in recent clinical trials to be effective in patients with relapsed disease.3 The recent approval of teclistamab is based on the promising results of the ongoing Phase I/II MajesTEC-1 study (NCT04557098). At a median follow-up of 14.1 months, an overall response rate (ORR) of 63% was observed, with 39.4% of patients demonstrating a complete response (CR) or better.4 Furthermore, the median duration of response observed was 18.4 months, and the median duration of progression-free survival (PFS) was 11.3 months.4 The most common adverse events (AEs) were cytokine release syndrome (CRS), neutropenia, anemia, thrombocytopenia, and low-grade immune effector cell-associated neurotoxicity (ICANS).4

Prof. Hermann Einsele, MD, FRCP, University of Würzburg, Würzburg, Germany, shared some insights into the safety and efficacy of teclistamab and updates from the MajesTEC-1 trial at the 2022 European Hematology Association (EHA) Congress. Prof. Einsele emphasizes the promise of this agent in patients with triple-class refractory disease, saying, “What’s very clear is that the efficacy is really surprisingly high; we have an overall response rate which is beyond 60%, the complete remission rate is approaching 30%, so it’s a very effective treatment in heavily pre-treated patients.”

The approval of this agent by the EMA is extremely promising and provides more hope for patients with R/R disease.


  1. ESMO. EMA recommends granting a conditional marketing authorisation for teclistamab. Available from https://www.esmo.org/oncology-news/ema-recommends-granting-a-conditional-marketing-authorisation-for-teclistamab. (Last accessed 31/08/2022).
  2. Kumar S, Baizer L, Callander NS, et al. Gaps and opportunities in the treatment of relapsed-refractory multiple myeloma: Consensus recommendations of the NCI Multiple Myeloma Steering Committee. Blood Cancer Journal. 2022 June 29;12(6):98.
  3. Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. New England Journal of Medicine. 2022 August 11;387(6):495-505. 
  4. Johnson & Johnson. Updated data for Janssen’s bispecific teclistamab suggest continued deep and durable responses in the treatment of patients with relapsed or refractory multiple myeloma. Available from: https://www.jnj.com/updated-data-for-janssens-bispecific-teclistamab-suggest-continued-deep-and-durable-responses-in-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma (Last accessed 31/08/2022).

Written by Anya Dragojlovic Kerkache
Edited by Thomas Southgate