On March 5, Johnson & Johnson announced that the U.S. FDA has approved the combination therapy of teratumab and daratumumab (subcutaneous injection ) for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received at least one prior line of therapy (including proteasome inhibitors and immunomodulatory agents) . Johnson & Johnson's press release stated that this combination therapy is expected to become a new standard of care for second-line treatment of MM.Teritumumab is the world's first approved BCMA×CD3 bispecific antibody , previously approved for late- line treatment of multiple myeloma , with sales of $670 million in 2025 (+22.1%) . Daratumumab subcutaneous injection has previously been approved for the treatment of several different MM indications. In 2025 , global sales of daratumumab (intravenous + subcutaneous) reached $14.351 billion .
This approval for the new indication is based on data from the ongoing Phase III MajesTEC-3 study. This is a randomized controlled trial designed to evaluate the safety and efficacy of teratumab plus daratumumab compared to the investigator-selected daratumumab plus dexamethasone (gapomalidine or bortezomib) regimen in patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one first-line therapy .
In patients with recurrent partial mitochondrial disease (RRMM), after a median follow-up of three years, the teratumab plus daratumumab subcutaneous injection group showed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to the standard treatment group. Results showed that, compared to the standard treatment regimen, the treatment group reduced the risk of disease progression or death by 83% (hazard ratio [HR] 0.17; P < 0.0001) ; the three-year PFS rate was 83% , compared to 30% in the control group, highlighting the durable efficacy of this therapy.
Meanwhile, compared with the standard treatment regimen (SOC) , the treatment group also observed significant improvements in key secondary endpoints, including treatment response rate, negative minimal residual disease (MRD) , overall survival, and time to symptom exacerbation.
Data showed that the treatment regimen demonstrated a higher overall response rate (89.0% vs. 75.3%) , complete response rate (81.8% vs. 32.1%) , and minimal residual disease negativity rate (58.4% vs. 17.1% ) at three-year follow-up. In terms of overall survival (OS), the treatment regimen was superior (HR, 0.46) . In all pre-specified subgroups, the treatment group had better OS than the control group (HR, 0.46) . At three years, the OS rates for the treatment group and the control group were 83.3% and 65.0%, respectively.
In the MajesTEC-3 study, the incidence of grade 3/4 treatment-related adverse events was similar in the treatment and control groups (95.1% vs. 96.6%) .
Currently, globally approved BCMA×CD3 bispecific antibody drugs include Pfizer's Elranatamab and Regeneron's Linvoseltamab , both used to treat relapsed/refractory multiple myeloma (RRMM). BCMA×CD3 drugs under development include TNB-383B (AbbVie) and REGN5458 (Regeneron) .

https://mp.weixin.qq.com/s/I4vHIM8v6yU5R6NSwJ3CtQ