J&J's teclistamab wins CHMP backing for second-line myeloma use
Johnson & Johnson has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending an indication extension for teclistamab (TECVAYLI) to cover adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy. The recommendation, announced on 18 September 2026, moves the bispecific antibody meaningfully earlier in the treatment sequence and is supported by Phase 3 data showing improvements in both progression-free and overall survival.
The CHMP opinion follows data from the MajesTEC-9 study (NCT05572515), a randomised Phase 3 trial comparing teclistamab monotherapy against two standard-of-care doublet regimens, pomalidomide plus bortezomib and dexamethasone (PVd), or carfilzomib plus dexamethasone (Kd), in patients who had received one to three prior lines including an anti-CD38 monoclonal antibody and lenalidomide. Results, published in the New England Journal of Medicine, showed a 71% reduction in the risk of disease progression or death (hazard ratio 0.29; 95% CI 0.23–0.38; p less than 0.001) and a 40% reduction in the risk of death (HR 0.60; 95% CI 0.43–0.83; p = 0.002). Nearly two-thirds of patients on teclistamab achieved a complete response or better (65.9% versus 16.8%).
Safety profile and treatment duration
The safety data broadly reflected teclistamab's established profile. Grade 3/4 adverse events occurred in 84.9% of patients on teclistamab compared with 76.3% on standard of care, and Grade 5 events in 6.5% versus 3.5%. Infection rates were higher in the teclistamab arm (Grade 3/4: 41.6% versus 29.0%), though the company notes these declined over time. Median treatment duration was 13.1 months on teclistamab versus 7.0 months on the comparator regimens, reflecting the deeper and more durable responses observed.
Ester in 't Groen, EMEA Therapeutic Area Head for Haematology at Johnson & Johnson, said the positive opinion "reinforces teclistamab's potential as a foundational immunotherapy after first-line treatment" and highlighted the availability of both steroid-sparing combination and monotherapy regimens as expanding patient choice.
Competitive and regulatory context
This recommendation builds on a separate European Commission approval granted in August 2026, which cleared teclistamab in combination with daratumumab for RRMM from the second line onwards, based on MajesTEC-3 data published in the New England Journal of Medicine. Together, the two Phase 3 programmes give J&J a dual-regimen foothold in the second-line setting, a commercially critical segment where treatment decisions have historically been shaped by proteasome inhibitor and immunomodulatory agent combinations.
The broader competitive landscape for BCMA-targeted therapies in multiple myeloma has intensified considerably. Bristol Myers Squibb's elranatamab and Pfizer's elranatamab-bcmm, along with GSK's belantamab mafodotin, are among the agents vying for positioning across relapsed lines. The shift of bispecific antibodies into earlier lines of therapy, where patient populations are larger and remission depth matters more to long-term outcomes, represents the next strategic battleground for the class.
More than 30,700 patients have now received teclistamab globally, according to J&J's own data, providing a substantial real-world safety dataset that is likely to support payer negotiations and guideline inclusion across EU member states. The formal European Commission decision, which typically follows a positive CHMP opinion within two to three months, is anticipated before the end of 2026. Clinicians and investors will watch whether the label extension translates into earlier treatment initiation in practice, given that anti-CD38 refractoriness is already a defining feature of the eligible population.