CHMP Recommends Approval for Teclistamab in Relapsed/Refractory Multiple Myeloma

BEERSE, BELGIUM, Sept. 18, 2026 (GLOBE NEWSWIRE), The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension for Johnson & Johnson’s TECVAYLI® (teclistamab) for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. This recommendation follows the positive results of the Phase 3 MajesTEC-9 study (NCT05572515), which evaluated the efficacy and safety of teclistamab as a monotherapy compared to standard of care regimens (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.

The results of the MajesTEC-9 study demonstrated significantly improved progression-free and overall survival for patients treated with teclistamab. Specifically, treatment with teclistamab reduced the risk of disease progression or death by 71% (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38; p<0.001) and the risk of death by 40% (HR, 0.60; 95% CI, 0.43-0.83; p = 0.002) compared to standard of care. Additionally, nearly two-thirds of patients achieved a complete response or better (65.9% vs. 16.8%; p<0.001).

The safety profile of teclistamab in the study was consistent with its known safety profile. The median duration of treatment on teclistamab was 13.1 months, almost twice as long as on standard of care (7.0 months). Adverse events (AEs) were observed in 99.7% of teclistamab recipients versus 97.9% of those receiving standard of care. Grade 3/4 AEs occurred in 84.9% of teclistamab recipients versus 76.3% of those receiving PVd or Kd. Grade 5 AEs occurred in 6.5% of teclistamab recipients versus 3.5% of those receiving standard of care. Infections were more frequent with teclistamab (Grade 3/4, 41.6% vs. 29.0%), but rates of Grade 3 or higher infections decreased over time.

Johnson & Johnson has a long-standing commitment to transforming outcomes for patients with multiple myeloma by advancing innovative therapies. Teclistamab, a subcutaneous bispecific antibody, has the potential to expand the choices for patients living with the disease and redefine what’s possible in multiple myeloma. The company’s expertise in Innovative Medicine and MedTech positions it uniquely to innovate across the full spectrum of healthcare solutions, delivering breakthroughs that can profoundly impact health for humanity.

In August 2022, teclistamab received European Commission (EC) approval 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. In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. 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.

TECVAYLI® is an off-the-shelf (or ready-to-use) bispecific antibody, currently being evaluated in several combination studies. To date, more than 30,700 patients have been treated worldwide with teclistamab.