Johnson & Johnson announced FDA approval of Tecvayli (teclistimab-cqyv) plus Darzalex Faspro (daratumumab and haluronidase-fihj) as a treatment for relapsed or refractory multiple myeloma (RRMM) on March 5th, 2026. The treatment is indicated for patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, according to a company press release.
FDA approval was based on results from MajesTEC-3, a Phase III clinical trial evaluating 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. The study found that patients treated with teclistamab plus daratumumab had an 83% reduction in the risk of disease progression or death compared to the cohort given the traditional standard of care. Significant improvements were also observed in secondary endpoints like treatment response rates, minimal residual disease-negativity, overall survival, and time to worsening of symptoms, according to the release.
“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,” said Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program, University of Alabama at Birmingham, and Primary Investigator of MajesTEC-3, in the release. “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.”
“As the leader in hematology, we have a proud history of transforming the treatment landscape for multiple myeloma. 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,” said Imran Khan, M.D., Ph.D., Vice President, U.S. Hematology Medical Affairs, Johnson & Johnson. “The FDA approval of [teclistamab plus daratumumab] adds a powerful new treatment option to our multiple myeloma portfolio, moving us closer to our ambition of one day curing this disease.”
Teclastamab is a first-in-class, bispecific T-cell engager antibody therapy designed to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. Prior to this approval, it received accelerated approval from FDA in October 2022 as an off-the-shelf treatment for patients with RRMM who received at least four prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody.
