FDA approves TECVAYLI (teclistamab) plus DARZALEX FASPRO for relapsed or refractory multiple myeloma after prior therapy, supported by Phase 3 MajesTEC-3 trial showing significant PFS and OS benefits.
Written By: Nikita Chaudhari, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration has approved TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. The regimen may be used as early as second-line treatment and expands options for patients who relapse after initial therapy.
TECVAYLI is a bispecific T-cell engager that binds CD3 on T-cells and B-cell maturation antigen (BCMA) on myeloma cells, redirecting immune cells to eliminate malignant plasma cells. DARZALEX FASPRO is a subcutaneous CD38-directed monoclonal antibody. In combination, the therapies enhance immune-mediated targeting of BCMA-expressing myeloma cells.
The approval is based on the Phase 3 MajesTEC-3 trial (NCT05083169), which compared teclistamab plus daratumumab with daratumumab, dexamethasone, and either pomalidomide or bortezomib in patients previously treated for multiple myeloma.
After three years of follow-up, the combination reduced the risk of disease progression or death by 83% (HR 0.17). The three-year progression-free survival rate was 83% versus 30% in the control arm.
Overall survival also favored the combination (HR 0.46), with three-year survival rates of 83.3% compared with 65.0%. Response outcomes were higher across key endpoints, including overall response (89.0% vs 75.3%), complete response or better (81.8% vs 32.1%), and minimal residual disease negativity (58.4% vs 17.1%).
The data were presented at the 2025 American Society of Hematology Annual Meeting and published in The New England Journal of Medicine.
Grade 3 or 4 treatment-emergent adverse events occurred in 95.1% of patients receiving the combination and 96.6% in the control group, most commonly cytopenias and infections. Cytokine release syndrome occurred in 60.1% of patients, all Grade 1 or 2 and manageable with standard treatment protocols.
Immune effector cell-associated neurotoxicity syndrome occurred in 1.1% of patients, and treatment discontinuations due to adverse events were low.
The supplemental biologics license application was selected for the FDA’s Commissioner’s National Priority Voucher Pilot Program and also received Breakthrough Therapy Designation and Real-Time Oncology Review.
TECVAYLI first received accelerated FDA approval in 2022 for patients with relapsed or refractory multiple myeloma after at least four prior therapies, and more than 23,000 patients worldwide have received the drug. DARZALEX FASPRO, approved in 2020, used across multiple myeloma treatment settings.
Multiple myeloma is a malignancy of plasma cells in the bone marrow and the third most common blood cancer worldwide. In the United States, more than 35,000 people are diagnosed each year, and the five-year survival rate is approximately 60%.
For detailed information on adverse reactions, boxed warnings, precautions, and other safety considerations, see the full U.S. Prescribing Information: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TECVAYLI-pi.pdf
References
Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line, 05 March 2026, Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line
Costa LJ et al, MajesTEC-3 Trial Investigators. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2026 Feb 19;394(8):739-752. Epub 2025 Dec 9. PMID: 41363801, https://doi.org/10.1056/nejmoa2514663
A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants with Relapsed or Refractory Multiple Myeloma (MajesTEC-3), ClinicalTrials.gov ID NCT05083169, https://clinicaltrials.gov/study/NCT05083169
About Writer
Nikita Santosh Chaudhari, BPharm
She is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, particularly inclined towards publication writing and scientific content development. In her words, she is enthusiastic about scientific documentation and publication writing, aiming to contribute to accurate, ethical, and evidence-based medical communication.