The U.S. Food and Drug Administration today approved teclistamab in combination with daratumumab hyaluronidase-fihj, Tec-Dara, to treat adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. This decision, which was issued 55 days after filing, marks the third approval under the new Commissioner’s National Priority Voucher (CNPV) pilot program. 

The FDA proactively awarded a voucher for the drug combination on December 15, 2025, after FDA leaders learned about a Phase 3 clinical trial study in which Tec-Dara showed significant improvements over the standard of care in both progression-free survival and overall survival. Notably, in that study, Tec-Dara reduced the risk of disease progression or death by 83% relative to the standard of care control arm.

“The FDA is now proactively moving to cut idle time to accelerate meaningful treatments for the American people,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Multiple myeloma is notoriously challenging to treat. When we saw the most impressive second-line myeloma trial results in history, we acted quickly to bring this finding to everyday Americans wrestling with the disease.”

The CNPV program seeks to expedite approval of applications that address critical national health priorities, such as bringing innovative therapies to the American people, addressing large unmet medical needs, promoting domestic manufacturing, and increasing affordability. A company selected for the program is issued a voucher entitling the company to benefits including enhanced communications and rolling review to allow for a shortened review time.

“It is very exciting to see such a rapid FDA approval of this groundbreaking treatment for one of the most common blood cancers,” said Tracy Beth Høeg, M.D., Ph.D., Acting Director of the FDA’s Center for Drug Evaluation and Research. “Tec-Dara was found in a randomized trial to reduce the risk of death by over 50% compared with current standard of care in patients with relapsed refractory multiple myeloma. I am very grateful to the FDA scientists involved in this thorough and efficient review.”

Additionally, the Phase 3 study supporting the Tec-Dara indication provided confirmatory evidence for the existing indication of Tecvayli (teclistamab-cqyv) used as monotherapy, which will be converted from accelerated approval to traditional approval.  The prescribing information for Tecvayli comes with a Boxed Warning for life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). CRS is a severe inflammatory response, which causes high fever, low blood pressure, and in some cases death. Because of these risks, Tec-Dara is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the Tecvayli-Talvey REMS.

In addition to CRS, the most common side effects of Tecvayli in combination with daratumumab hyaluronidase-fihj include hypogammaglobulinemia (low antibody levels), upper respiratory tract infection, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia (fever), headache, nausea, gastroenteritis and decreased weight.

The FDA granted the approval to Janssen Biotech, Inc.

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