European Commission Approves Expanded Indication for Teclistamab Monotherapy as Treatment for Relapsed/Refractory Myeloma
EC approval was based on phase 3 MajesTEC-9 results, which showed a 71% reduction in the risk of disease progression or death, and a 40% reduction in the risk of death compared with standard of care: pomalidomide, bortezomib, and dexamethasone (PVd); or carfilzomib and dexamethasone (Kd).
On Friday, October 23, the European Commission (EC) approved an expanded indication for TECVAYLI® (teclistamab) monotherapy for adults with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy, as announced by Johnson & Johnson in a press release.
The approval introduces another treatment option in the second-line setting, following the EC’s August 2026 approval of teclistamab in combination with daratumumab.
The decision is supported by results from the phase 3 MajesTEC-9 trial (NCT05572515), which demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) compared with standard-of-care regimens.
Survival benefits and response rates
In MajesTEC-9, teclistamab reduced the risk of disease progression or death by 71% compared with standard care (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23–0.38; p<0.001). The risk of death was reduced by 40% (HR, 0.60; 95% CI, 0.43–0.83; p=0.002).
At 18 months, the PFS rate was 69.8% with teclistamab, compared with 26.9% with standard care. The 18-month OS rate was 79.2% versus 68.6%, respectively. Complete response or better (≥CR) was achieved by 65.9% of patients receiving teclistamab, compared with 16.8% of those receiving standard treatment (p<0.001).
The randomized phase 3 study compared teclistamab monotherapy, a bispecific T-cell engager, with either pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd). Participants had received one to three previous lines of therapy, including lenalidomide and an anti-CD38 monoclonal antibody. PFS was the primary endpoint; secondary endpoints included OS, response rates, duration of response, safety and patient-reported outcomes.
Safety findings
The safety profile of teclistamab was consistent with that established in previous studies, although severe adverse events and infections were more frequent with teclistamab than with standard treatment.
Adverse events of any grade occurred in 99.7% of patients receiving teclistamab and 97.9% receiving standard care. Grade 3 or 4 adverse events occurred in 84.9% and 76.3%, respectively, while Grade 5 adverse events occurred in 6.5% and 3.5%.
Grade 3 or 4 infections were reported in 41.6% of patients receiving teclistamab, compared with 29.0% receiving standard care. The reported rates of Grade 3 or higher infections decreased over time. Median treatment duration was 13.1 months with teclistamab and 7.0 months with standard treatment.
Updated dosing schedule
The revised product information will replace the existing monotherapy indication and dosing instructions. It introduces monthly dosing from month seven onward, with eligible patients able to transition to monthly administration as early as month three. The change is intended to simplify treatment and potentially reduce the burden of more frequent dosing.
Mechanism of action and clinical context
Teclistamab is a bispecific antibody administered by subcutaneous injection. It binds to B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells, bringing the immune cells into proximity to help them target and kill cancer cells.
The EC first approved TECVAYLI in August 2022 for patients with RRMM who had received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose disease had progressed on their most recent treatment. The August 2026 approval of teclistamab plus daratumumab expanded its use into earlier treatment lines.
The latest decision further expands the potential use of teclistamab-based treatment at first relapse. However, the MajesTEC-9 safety findings, particularly the rates of severe adverse events and infections, remain important considerations when evaluating the treatment’s benefits and risks.
Teclistamab is subject to additional monitoring under European medicines regulations. Patients and healthcare professionals should consult the European Medicines Agency’s Summary of Product Characteristics for complete information on indications, dosing, contraindications, warnings and adverse reactions.
References:
European Commission approves Johnson & Johnson’s TECVAYLI®▼ (teclistamab) monotherapy for relapsed/refractory multiple myeloma, expanding treatment options from first relapse. Johnson & Johnson press release. October 23, 2026.
Touzeau C, Mina R, Quach H, Hungria V, Bhutani D, Chen W, Kumar S, Chaulagain C, Dimopoulos MA, Bahlis NJ, Maral S, van de Donk NWCJ, Schmidt Filho J, Saja K, Teipel R, Ando M, Roeloffzen W, Annibali O, Augustson B, Botta C, Delforge M, Bourgeois E, Buda G, Hus M, Perrot A, Preis M, Beksac M, Pour L, Farmer S, Nunes M, Oriol A, Melchardt T, Hu Y, Flogegård M, Wang D, Pei L, Wroblewski S, Ariës IM, Quijano Cardé NA, Perova T, de Jager T, Yeh TM, Vanquickelberghe V, Shah P, Chastain K, Kobos R, Carson R, Landgren O; MajesTEC-9 Trial Investigators. Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy. N Engl J Med. 2026 Jul 30;395(5):440-453. doi: 10.1056/NEJMoa2603870.
Tecvayli Summary of Product Characteristics. European Medicines Agency.