FDA Approves Tec-Dara for Relapsed or Refractory Multiple Myeloma

On March 5, 2026, the U.S. Food and Drug Administration (FDA) approved the combination treatment of teclistamab and daratumumab hyaluronidase-fihj, branded as Tec-Dara, for adult patients with relapsed or refractory multiple myeloma who have undergone at least one prior line of therapy. This approval marks the third under the FDA's Commissioner’s National Priority Voucher (CNPV) pilot program, designed to expedite the review of applications addressing critical health priorities. The FDA's decision was made 55 days after the application was filed, significantly shorter than the typical review period of 10 to 12 months.

FDA - Food and Drug AdministrationReutersPhase 3 Trial Points to a Potential New Standard of Care for Early Relapsed MM

The approval was based on a Phase 3 clinical trial that demonstrated Tec-Dara's efficacy, showing an 83% reduction in the risk of disease progression or death compared to the standard of care. The trial involved 587 participants with relapsed or refractory multiple myeloma, with the Tec-Dara group achieving a progression-free survival rate of 83.4% at 36 months, compared to 29.7% for the control group receiving daratumumab and dexamethasone with either pomalidomide or bortezomib.

Phase 3 Trial Points to a Potential New Standard of Care for Early Relapsed MM

FDA Commissioner Marty Makary emphasized the importance of rapid approval for innovative treatments, stating, “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.” Tracy Beth Høeg, Acting Director of the FDA’s Center for Drug Evaluation and Research, noted the significance of the rapid approval, calling it “exciting” for patients facing one of the most common blood cancers.

FDA - Food and Drug Administration

Despite its efficacy, Tec-Dara is associated with serious risks, including life-threatening cytokine release syndrome (CRS) and neurologic toxicity. As a result, it is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Common side effects include hypogammaglobulinemia, upper respiratory tract infections, and fatigue. The prescribing information includes a Boxed Warning to inform healthcare providers and patients of these risks.

FDA - Food and Drug AdministrationPhase 3 Trial Points to a Potential New Standard of Care for Early Relapsed MMReuters

While the approval has been largely welcomed, some experts express caution regarding the long-term implications of rapid approvals under the CNPV program. Concerns have been raised about the potential for insufficient post-marketing surveillance and the need for ongoing monitoring of long-term safety and efficacy.

FDA - Food and Drug Administration

The approval of Tec-Dara is expected to influence future treatment protocols for multiple myeloma, potentially establishing it as a new standard of care for patients experiencing early relapse. Ongoing research and clinical trials will continue to assess its long-term effectiveness and safety profile.

FDA - Food and Drug Administration

• “The FDA is now proactively moving to cut idle time to accelerate meaningful treatments for the American people,” — Marty Makary, M.D., M.P.H., FDA Commissioner

FDA - Food and Drug Administration

• “It is very exciting to see such a rapid FDA approval of this groundbreaking treatment for one of the most common blood cancers,” — Tracy Beth Høeg, M.D., Ph.D., Acting Director, FDA’s Center for Drug Evaluation and Research

FDA - Food and Drug Administration

• “a new SoC for RRMM as early as first relapse.” — María-Victoria Mateos, Researcher

Phase 3 Trial Points to a Potential New Standard of Care for Early Relapsed MM