The U.S. Food and Drug Administration has approved a new combination therapy, Tec-Dara, for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one previous line of therapy.

The treatment combines teclistamab with daratumumab hyaluronidase-fihj and received regulatory clearance just 55 days after submission. The approval marks the third drug cleared under the Commissioner’s National Priority Voucher (CNPV) pilot programme designed to accelerate review of therapies addressing major health needs.

The approval was granted to Janssen Biotech, after the FDA proactively awarded the company a priority voucher in December 2025. Agency officials issued the voucher after reviewing results from a phase III clinical trial showing significant benefits compared with standard treatment options.

In the study, the Tec-Dara regimen demonstrated strong clinical outcomes, reducing the risk of disease progression or death by 83 percent compared with the control arm. The therapy also showed substantial improvement in overall survival among patients with relapsed or treatment-resistant disease.

FDA Commissioner Marty Makary said the agency is working to eliminate unnecessary delays in drug approvals to ensure promising therapies reach patients faster. He highlighted the trial results as among the most significant second-line treatment outcomes seen in multiple myeloma.

The CNPV pilot programme was created to speed up review of medicines that address urgent national health priorities. Companies selected for the initiative receive benefits such as enhanced communication with regulators and rolling submission reviews, helping reduce approval timelines.

According to Tracy Beth Høeg, Acting Director of the FDA’s Centre for Drug Evaluation and Research, the trial results showed the Tec-Dara therapy reduced the risk of death by more than half compared with the existing standard of care for relapsed refractory multiple myeloma.

Data from the phase III trial also supported confirmation of the previously granted accelerated approval of Tecvayli (teclistamab-cqyv) as a standalone therapy. Based on the new evidence, the monotherapy indication will now transition to traditional approval.

However, the prescribing information for Tecvayli includes a boxed warning for potentially life-threatening side effects such as cytokine release syndrome and neurological toxicity, including immune effector cell-associated neurotoxicity syndrome. Due to these risks, the Tec-Dara combination will be available only through a restricted distribution programme under a Risk Evaluation and Mitigation Strategy known as the Tecvayli-Talvey REMS.

Common adverse reactions reported with the combination therapy include low antibody levels, respiratory infections, cough, diarrhoea, musculoskeletal pain, pneumonia, fatigue, fever, headache, nausea and weight loss.