Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has approved Tecvayli® (teclistamab-cqyv) plus Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.1
Tecvayli and Darzalex Faspro work synergistically to prime and activate the immune system to eradicate myeloma cells that express the BCMA protein.1
This approval offers a potential new standard of care (SOC) as early as second line and brings a novel treatment approach for the 40% of patients with multiple myeloma who experience disease relapse.2
They demonstrated statistically significant improvements in PFS in patients with RRMM compared to standard treatment after a median follow-up of three years in patients with RRMM.
The results were presented in December 2025 as a late-breaking oral presentation at the American Society of Haematology (ASH) Annual Meeting with simultaneous publication in The New England Journal of Medicine.
Unprecedented MajesTEC-3 study results
The approval is based on data from the phase 3 MajesTEC-3 study, an ongoing, phase 3 randomised 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 RRMM who have received at least one prior line of therapy.
Tecvayli in combination with Darzalex Faspro demonstrated statistically significant improvements in PFS and OS in patients with RRMM compared to standard treatment after a median follow-up of three years in patients with RRMM. 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).3
The three-year PFS rate was 83% compared to 30% in the control arm, underscoring a durable benefit.3 The results were presented in December 2025 as a late-breaking oral presentation at the American Society of Hematology (ASH) Annual Meeting with simultaneous publication in The New England Journal of Medicine.
Significant improvements compared to SOC were observed across key secondary endpoints, including treatment response rates, minimal residual disease (MRD)-negativity, OS, and time to worsening of symptoms – revealing the impact of the regimen across varied patient measures.3
The FDA proactively selected the teclistamab MajesTEC-3 supplemental Biologics License Application (sBLA) to participate in the Commissioner’s National Priority Voucher (CNPV) Pilot Program as it aligns with the program’s priority to deliver more innovative therapies for American people.
The FDA also granted the application Breakthrough Therapy Designation and Real-Time Oncology Review.
References
1 TECVAYLI® U.S. Prescribing Information.
2 Kumar, S. K., et al. (2021). Prognostic factors for early (<2 years) and late (>2 years) relapse after initial therapy in multiple myeloma. Blood, 138(Supplement 1), 3761. https://doi.org/10.1182/blood-2021-151249
3 Maria-Victoria Mateos, et. al., Phase 3 Randomized Study of Teclistamab Plus Daratumumab Versus Investigator’s Choice of Daratumumab and Dexamethasone With Either Pomalidomide or Bortezomib (DPd/DVd) in Patients With Relapsed Refractory Multiple Myeloma (RRMM): Results of MajesTEC-3, 2025 American Society of Hematology Annual Meeting. Accessed December 2025.
4 MajesTEC-3, NCT05083169. A Phase 3 Randomized Study Comparing Teclistamab + Subcutaneous Daratumumab (Tec-Dara) Versus Daratumumab SC + Pomalidomide + Dexamethasone (DPd) or Daratumumab SC + Bortezomib + Dexamethasone (DVd). https://clinicaltrials.gov/study/NCT05083169. Accessed December 2025.
5 U.S. FDA Approves TECVAYLI® (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma. Accessed December 2025.
6 DARZALEX FASPRO® U.S. Prescribing Information.
7 DARZALEX® U.S. Prescribing Information.
8 Rajkumar SV. Multiple Myeloma: 2020 Update on Diagnosis, Risk-Stratification and Management. Am J Hematol. 2020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178.
9 National Cancer Institute. Plasma cell neoplasms. National Institutes of Health. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq. Accessed October 2025.
10 City of Hope. Multiple myeloma: Causes, symptoms & treatments. https://www.cancercenter.com/cancer-types/multiple-myeloma. Accessed December 2025.
11 American Cancer Society. Myeloma cancer statistics. https://cancerstatisticscenter.cancer.org/types/myeloma. Accessed December 2025.
12 SEER Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute. https://seer.cancer.gov/explorer/. Accessed December 2025.
13 American Cancer Society. What is multiple myeloma? https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed December 2025.
14 American Cancer Society. Multiple myeloma early detection, diagnosis, and staging. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html. Accessed December 2025.
