A Type II variation application has been submitted to the European Medicines Agency (EMA) seeking the approval of teclistamab (Tecvayli) monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy.1
The application is supported by data from the phase 3 MajesTEC-9 trial (NCT05572515), which showed that teclistamab reduced the risk of disease progression or death by 71% compared with standard-of-care (SOC) therapy (HR, 0.29; 95% CI, 0.23-0.38).2 Additionally, teclistamab reduced the risk of death by 40% compared with SOC treatment (HR, 0.60; 95% CI, 0.43-0.83). The progression-free survival (PFS) and overall survival (OS) outcomes, which were announced in January 2026, will be shared in further detail at a future medical meeting.
“A significant number of patients with multiple myeloma continue to relapse and become refractory to currently available therapies, representing one of the largest and most challenging unmet needs in the disease,” Ester in ’t Groen, EMEA Therapeutic Area head, Haematology, at Johnson & Johnson, stated in a news release.1 “Making teclistamab monotherapy available to patients as early as second line, where it has the potential to meaningfully improve long-term outcomes and change the course of the disease, could bring new hope to patients and their families.”
Teclistamab is currently approved by the European Commission (EC) for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 3 prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. Following this August 2022 approval, the EC also approved a reduced dosing frequency for teclistamab at 1.5mg/kg every 2 weeks in patients who have achieved a complete response (CR) or better for a minimum of 6 months in August 2023.
EU Approval Sought for Teclistamab in Second-Line R/R Myeloma
- A Type II variation application has been submitted to the EMA for teclistamab monotherapy in adult patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy.
- The application is supported by data from the phase 3 MajesTEC-9 trial, in which teclistamab improved PFS and OS vs SOC therapy.
- This approval would build upon the current indication for teclistamab in the EU, where it is approved for patients who have received at least 3 prior lines of therapy.
How was the MajestTEC-9 trial designed?
The multicenter, randomized, open-label phase 3 study enrolled patients at least 18 years of age diagnosed with multiple myeloma per International Myeloma Working Group criteria who had measurable disease.3 One to 3 prior lines of therapy were required, and they needed to include at least 2 consecutive cycles of an anti-CD38 monoclonal antibody and 2 consecutive cycles of lenalidomide (Revlimid) in any prior line of treatment. Disease progression or lack of response to the last line of therapy was also required, as was an ECOG performance status of 0 to 2.
Patients who received any prior BCMA-targeting agents were not permitted to enroll, and patients needed to eligible to receive the control regimen of pomalidomide (Pomalyst), bortezomib (Velcade), and dexamethasone (PVd).
Enrolled patients were randomly assigned to received subcutaneous teclistamab or a control regimen of PVd or carfilzomib plus dexamethasone (Kd), based on the principal investigator’s choice during part 1 of the study. The regimens were compared in part 1, and an alternative dosing regimen for teclistamab was also evaluated in part 2.
PFS and the incidence of cytokine release syndrome served as the trial’s primary end points. Secondary end points included overall response rate, very good partial response or better rate, CR or better rate, duration of response, time to next treatment, time to second progression, OS, and safety.
“At Johnson & Johnson, we are driven by a clear purpose to deliver innovations that redefine expectations of what a multiple myeloma diagnosis means to patients, at every stage of the disease,” Jordan Schecter, MD, vice president, Disease Area leader, Multiple Myeloma, at Johnson & Johnson, added in a news release.1 “With today’s regulatory milestone for teclistamab, we are advancing a widely available immunotherapy approach with the potential to support deep and sustained responses over time.”
References
- Tecvayli (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy. News release. Johnson & Johnson. March 10, 2026. Accessed March 10, 2026. https://www.jnj.com/media-center/press-releases/tecvayli-teclistamab-monotherapy-application-submitted-to-the-ema-for-relapsed-refractory-multiple-myeloma-after-at-least-one-prior-therapy
- 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. Johnson & Johnson. News Release. January 14, 2026. Accessed January 15, 2026. 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
- A study comparing teclistamab monotherapy versus pomalidomide, bortezomib, dexamethasone (PVd) or carfilzomib, dexamethasone (Kd) in participants with relapsed or refractory multiple myeloma (MajesTEC-9). Clinicaltrials.gov Updated February 13, 2025. Accessed March 10, 2026. https://clinicaltrials.gov/study/NCT05572515
