FDA approves Tec-Dara for relapsed or refractory multiple myeloma after expedited review

The U.S. Food and Drug Administration approved the combination of teclistamab (Tecvayli) and daratumumab hyaluronidase-fihj (Darzalex Faspro), branded Tec-Dara, to treat adult patients with relapsed or refractory multiple myeloma, the agency announced March 5, 2026.

The approval followed a December 2025 decision by the agency to award a national priority voucher under the Commissioner’s National Priority Voucher pilot program to the supplemental biologics license application, a designation that placed the filing among 16 therapies selected for accelerated review. The voucher was intended to shorten the review timeline and helped move Tec-Dara through the regulatory process more quickly than usual.

Regulatory reviewers cited data from the Phase 3 MajesTEC-3 study, which tested teclistamab plus subcutaneous daratumumab against two standard regimens—daratumumab plus pomalidomide and dexamethasone, and daratumumab plus bortezomib and dexamethasone. Peer-reviewed reporting of the trial appears in Costa et al., Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma, N Engl J Med 2025; DOI: 10.1056/NEJMoa2514663. Phase 3 results demonstrated significant improvements in progression-free and overall survival compared with standard care, and sponsors said safety profiles were comparable between arms.

Tecvayli itself received accelerated approval in October 2022 as the first bispecific BCMA-directed CD3 T-cell engager for patients who had received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. That initial approval came with priority review, breakthrough therapy and orphan drug designations. The teclistamab development program and the FDA’s previous analysis remain central to understanding risks for the combination regimen.

Earlier teclistamab data from MajesTEC-1 and FDA review documents show a single-agent overall response rate of 61.8 percent and a complete response or better rate of 28.2 percent at the recommended dosing schedule, which used step-up doses of 0.06 mg/kg and 0.3 mg/kg before a 1.5 mg/kg subcutaneous maintenance dose once weekly. Median follow-up among responders in that analysis was 7.4 months and median duration of response was not reached.

Safety remains a key concern. Teclistamab carries a boxed warning for life-threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome. FDA summaries list cytokine release syndrome in 72 percent of patients, neurologic toxicity in 57 percent, ICANS in 6 percent, grade 3 CRS in 0.6 percent, and grade 3 or 4 neurologic toxicity in 2.4 percent. Because of those risks, teclistamab is available only through a Risk Evaluation and Mitigation Strategy program designed to assure safe use.

Clinicians voiced guarded optimism about the approval and its potential long-term impact. "This gives us a highly effective option. For the first time, we are seeing a plateau in our curve, and maybe some of these patients with these immunotherapy-based approaches—which is now what we see with [daratumumab/teclistamab]—we'll see some with ciltacabtagene autoleucel [Carvykti] be cured in the long term. That, for me, is what I'm really hoping we will achieve in the next few years: for a proportion of patients, maybe a small proportion, that we'll be able to achieve a functional cure," said clinicians involved in reporting on the data.

Public health and equity questions now move to the fore. The combination’s monitoring needs, REMS requirements and likely high cost could limit access in community oncology clinics and safety-net settings, raising concerns about disparities in who benefits from what regulators called a potentially practice-changing regimen. Health systems, payers and manufacturers will face pressure to ensure training, distribution and affordability so the survival gains shown in trials reach diverse patient populations.

Healthcare professionals should report serious adverse events to FDA’s MedWatch at 1-800-FDA-1088. For help with single-patient INDs for investigational oncology products, contact the FDA Oncology Center of Excellence Project Facilitate at 240-402-0004 or OncProjectFacilitate@fda.hhs.gov.