Johnson & Johnson (J&J) has announced US FDA approval for Tecvayli (teclistamab-cqyv) plus Darzalex Faspro (daratumumab and hyaluronidase-fihj) to treat adults with relapsed or refractory multiple myeloma (RRMM).
The approval is based on data from the ongoing, randomised, phase 3 MajesTEC-3 study. The study is evaluating the safety and efficacy of teclistamab plus daratumumab versus standard of care in patients with RRMM who have received at least one previous treatment.
The treatment primes and activates the immune system to eradicate myeloma cells that express the BCMA protein.
Tecvayli plus Darzalex Faspro showed a statistically significant improvement of 83% in progression‑free survival (PFS) and overall survival (OS) after three years in patients with RRMM compared to 30% with standard treatment.
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.
Dr Luciano Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham, and Primary Investigator of MajesTEC-3, said: “This new treatment option can redefine how we approach RRMM treatment by giving healthcare providers a regimen with improvement in PFS and OS and a well-characterized safety profile.
“The option to use this regimen as early as second line is particularly important because patients with RRMM often experience multiple relapses and reduced responsiveness to therapy over time, which makes earlier treatment with the most effective therapies critical.
“In addition, the steroid-sparing approach may reduce toxicity and improve tolerability.”
Imran Khan, Vice President, US Hematology Medical Affairs at Johnson & Johnson, said: “This approval represents another pivotal milestone in improving outcomes for patients living with this disease, with a unique regimen accessible to patients across all practice settings.”
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.