Tec-Dara for the treatment of RRMM is the third FDA drug approval under the Commissioner's National Priority Voucher (CNPV) Pilot Program.

On Thursday, March 5, the U.S. Food and Drug Administration (FDA) approved teclistamab in combination with daratumumab hyaluronidase-fihj (Tec-Dara) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy.

The decision was issued 55 days after filing — the agency’s third approval under the new Commissioner’s National Priority Voucher (CNPV) pilot program.

The voucher for Tec-Dara was awarded by the FDA on December 15, 2025, based on the results of the MajesTEC-3 trial where Tec-Dara “showed significant improvements over the standard of care in both progression-free survival and overall survival,” while “reducing the risk of disease progression or death by 83% relative to the standard of care control arm,” states the FDA news release.

“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,” said FDA Commissioner Marty Makary, M.D., M.P.H.

Confirmatory evidence was provided by the Phase 3 trial for Tecvayli’s (teclistamab-cqyv) existing indication as monotherapy — to be converted from accelerated to traditional approval.

Prescribing information
A boxed warning is included in the prescribing information for Tecvayli 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,” said the FDA.
 
The most common side effects of Tec-Dara 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
• decreased weight
 
The CNPV Pilot Program
According to the FDA’s program overview, the CNPV pilot program “is being explored as a pathway to dramatically reduce review times for drug and biological product applications and manufacturing or efficacy supplements.” The innovative program “uses a collaborative tumor board-style review process to accelerate review and approval of products that align with one of five critical U.S. national health priorities,” which include public health crisis response, innovative breakthrough therapies, large unmet medical needs, onshoring and supply chain resilience, and affordability. To find out more about the program, visit FDA.gov.
 
Risk Evaluation and Mitigation Strategies (REMS)
According to the FDA, a Risk Evaluation and Mitigation Strategy (REMS) is “a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.” Learn more about REMS by visiting the FDA website on Drug Safety and Availability.
 
References:
FDA Grants Third Approval Under the National Priority Voucher Program. U.S. Food and Drug Administration News Release. March 5, 2026.

Commissioner's National Priority Voucher (CNPV) Pilot Program. U.S. Food and Drug Administration. Current as of February 9, 2026. 

Risk Evaluation and Mitigation Strategies (REMS). U.S. Food and Drug Administration. Current as of May 20, 2025.