FDA Approves Two Johnson & Johnson Multiple Myeloma Regimens in Early 2026

The U.S. Food and Drug Administration approved two Johnson & Johnson multiple myeloma regimens in early 2026. On March 5, 2026, the FDA approved Tecvayli (teclistamab-cqyv) plus Darzalex Faspro for relapsed/refractory multiple myeloma, and on January 27, 2026, the FDA approved Darzalex Faspro in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for newly diagnosed patients ineligible for autologous stem cell transplant.

The March approval for Tecvayli plus Darzalex Faspro is based on data from the Phase 3 MajesTEC-3 study, an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab versus investigator's choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in patients with relapsed/refractory multiple myeloma who have received at least one prior line of therapy. Tecvayli in combination with Darzalex Faspro demonstrated statistically significant improvements in progression-free survival and overall survival in patients with relapsed/refractory multiple myeloma compared to standard treatment after a median follow-up of three years. Results show an 83% reduction in the risk of disease progression or death compared to standard regimens (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001). The three-year progression-free survival rate was 83% compared to 30% in the control arm. At three years, overall survival rates were 83.3% and 65.0% for the Tecvayli plus Darzalex Faspro arm and the control arm, respectively.

Tecvayli plus Darzalex Faspro showed higher rates of overall response (89.0% vs. 75.3%; OR, 2.65; 95% CI, 1.68-4.18), complete response (≥CR) (81.8% vs. 32.1%; odds ratio [OR], 9.56; 95% CI, 6.47-14.14), and minimal residual disease-negativity (58.4% vs. 17.1%; OR, 6.78; 95% CI, 4.53-10.15, P<0.0001; evaluable rate of 89.3% vs. 63.0%) at three-years follow-up. Overall survival favored Tecvayli plus Darzalex Faspro (HR, 0.46; 95% CI, 0.32-0.65; P<0.0001) across all prespecified subgroups. The results were presented in December 2025 as a late-breaking oral presentation at the American Society of Hematology Annual Meeting with simultaneous publication in The New England Journal of Medicine.

In the MajesTEC-3 study, Tecvayli plus Darzalex Faspro and standard of care comparators had similar rates of Grade 3/4 (95.1% vs. 96.6%) treatment-emergent adverse events. Most Grade 3/4 events were due to cytopenias and infection. Infections were observed with Tecvayli and Darzalex Faspro (any grade, 96.5%; Grade 3/4, 54.1%) and DPd/DVd control (any grade 84.1%; Grade 3/4 43.4%). Grade 3 or higher infections with Tecvayli and Darzalex Faspro declined after the first 6 months of treatment consistent with use of established immunoglobulin supplementation and infection prophylaxis protocols, along with switch to monthly dosing. Cytokine release syndrome occurred in 60.1% of patients; all cases were Grade 1/2.

The January approval for D-VRd is based on the pivotal Phase 3 CEPHEUS study, which evaluated the efficacy and safety of D-VRd compared to bortezomib, lenalidomide and dexamethasone (VRd) in newly diagnosed multiple myeloma patients who were ineligible for autologous stem cell transplant or deferred autologous stem cell transplant as initial therapy. The trial enrolled 395 patients in 13 countries across North America, South America, and Europe. D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility.

Findings from CEPHEUS showed that at a median follow-up of 22 months, the overall minimal residual disease-negativity rate at a sensitivity of 10-5 (no cancer cells detected within 100,000 bone marrow cells) was 52.3 percent vs 34.8 percent with VRd (P<0.0005). At a median follow-up of 39 months, the proportion of patients achieving sustained minimal residual disease-negativity of ≥12 months almost doubled at 42.6 percent vs 25.3 percent (P<0.0003) and D-VRd also significantly reduced the risk of progression or death by 40 percent (hazard ratio [HR], 0.60; 95 percent confidence interval [CI], 0.41-0.88; P<0.0078) vs VRd. At a median follow-up of nearly 5 years (59 months), D-VRd significantly increased the depth of response with higher rates of complete response or better at 81.2 percent vs 61.6 percent with VRd. Overall survival data were not yet mature. The effectiveness of D-VRd has not been established in patients who refused autologous stem cell transplant as initial therapy.

The overall safety results of Darzalex Faspro+VRd were consistent with the adverse reactions seen for Darzalex Faspro and VRd. In the CEPHEUS study, the most common adverse events (≥20%) in patients with newly diagnosed multiple myeloma who received D-VRd were upper respiratory tract infection, sensory neuropathy, musculoskeletal pain, diarrhea, fatigue, edema, rash, motor dysfunction, COVID-19, constipation, sleep disorder, cough, pneumonia, renal impairment, dizziness, nausea, urinary tract infection, pyrexia, abdominal pain, dyspnea, decreased appetite, and bruising.

This approval marks the twelfth indication for Darzalex Faspro overall and fifth in newly diagnosed multiple myeloma. Multiple myeloma is a blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow. Multiple myeloma is the second most common blood cancer worldwide.