FDA approved Tecvayli (teclistamab-cqyv), a Johnson & Johnson drug developed for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one of line of treatment.

Results from the ongoing Phase 3 MajesTEC-3 study showed that patients treated with the medication in combination with Daralex Faspro showed statistically significant improvement over patients receiving standard treatment for RRMM. According to J&J, these patients had an 83% reduction in disease progression or death.

Did the study show results for secondary endpoints?

Significant improvements were also shown across multiple secondary endpoints, including:

• Treatment response rates
• Minimal residual disease negativity
• OS
• Time to worsening symptoms

In a press release, 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 Dr. Luciano J. Costa 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.”

In the same press release, president and CEO of the International Myeloma Foundation Heather Ortner Cooper also said, “There is a critical need to expand community-based treatment options for multiple myeloma patients, allowing them to receive care closer to home while respecting their individual treatment preferences. This approval enhances the therapeutic landscape, giving oncologists diverse options to personalize treatment plans for each patient.”

FDA proactively approved the drug after including it as part of the Commissioner’s National Priority Voucher program. According to J&J, the drug was selected to be part of the program because the agency believes it will provide the American people with an innovative therapy.

Johnson and Johnson’s vice president of US hematology medical affairs Imran Khan, MD, PhD, said in a press release, “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. The FDA approval of TECVAYLI plus DARZALEX FASPRO adds a powerful new treatment option to our multiple myeloma portfolio, moving us closer to our ambition of one day curing this disease.”

In January of this year, J&J also announced Tecvayli’s application to the European Medicines Agency for use in treating RRMM in combination with Darzalex.²

In a press release issued at the time, EMEA therapeutic area head of haematology at Johnson & Johnson Innovative Medicine Ester in ’t Groen said, “There remains a critical need for off-the-shelf treatment options that can achieve deep and durable responses at second line, when immune function is better preserved. Teclistamab and daratumumab SC is the first off-the-shelf immunotherapy combination to demonstrate significant improvements in progression-free and overall survival in relapsed/refractory multiple myeloma as early as second line treatment, compared to current standards of care.”

Sources

1. 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. Johnson and Johnson. March 5, 2026. https://www.jnj.com/media-center/press-releases/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
2. Johnson & Johnson submits application to the European Medicines Agency for TECVAYLI® (teclistamab) in combination with DARZALEX® (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma. Johnson and Johnson. January 6, 2026. Accessed March 5, 2026. https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-application-to-the-european-medicines-agency-for-tecvayli-teclistamab-in-combination-with-darzalex-daratumumab-subcutaneous-formulation-for-patients-with-relapsed-refractory-multiple-myeloma