CHMP-EMA issues positive opinion on Tecvayli (teclistamab) for relapsed/refractory myeloma, with new recommendations on marketing authorization
On Thursday, June 25, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) “adopted a positive opinion recommending a change to the terms of marketing authorization for the medicinal product, Tecvayli (teclistamab),” according to the EMA website.
New and full indications adopted by the CHMP for Tecvayli (teclistamab) include:
1. Teclistamab “in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.”
2. Teclistamab “as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, 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.”
According to Johnson & Johnson, the CHMP’s recommendation is “supported by unprecedented Phase 3 data" from the MajesTEC-3 trial, "demonstrating that Tecvayli in combination with [subcutaneous] daratumumab achieved statistically significant improvements in progression-free and overall survival versus standard of care.”
The Phase 3 MajesTEC-3 trial, with nearly three years of follow-up, showed that teclistamab plus daratumumab SC reduced the risk of disease progression or death by 83.4% compared with standard of care (HR, 0.17; 95% CI, 0.12–0.23; p<0.0001) and improved overall survival (HR, 0.46; 95% CI, 0.32–0.65; p<0.0001), with benefits seen across all prespecified patient subgroups.
At three years, overall survival was 83.3% with the combination versus 65.0% with standard of care, and more than 90% of patients who were progression-free at six months remained progression-free at three years, indicating durable disease control.
“Pending approval, this novel complementary immunotherapy combination is positioned to delay disease progression for patients treated as early as second line, with 83% of patients alive at three years,” Johnson & Johnson stated.
According to the CHMP, “detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorization has been granted by the European Commission.”
References:
Tecvayli – opinion on variation to marketing authorization. European Medicines Agency. June 25, 2026.
CHMP recommendation advances Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab as a potential standard of care for relapsed/refractory multiple myeloma. Johnson & Johnson press release. June 26, 2026.