Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for its combination treatment of Tecvayli and Darzalex as a second-line therapy for multiple myeloma. The FDA announced the decision on Thursday, noting that it came just 55 days after the company submitted its application.
The accelerated review was made possible through the Commissioner’s National Priority Voucher (CNPV), which J&J was granted in December 2025. This program allows for expedited evaluation of therapies that meet certain national priorities, including addressing unmet medical needs or supporting government efforts to lower drug costs under the Most Favored Nation directive. Under this initiative, companies can expect regulatory decisions within one to two months, compared to the usual ten to twelve months.
“When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly,” said Commissioner Marty Makary at the time.
Tecvayli is designed as a bispecific antibody targeting both BCMA proteins on cancer cells and CD3 receptors on T cells, aiming to enhance immune response against multiple myeloma. Darzalex targets and blocks CD38 markers on cancer cells, promoting their destruction.
Data from the Phase 3 MajesTEC-3 study showed that combining these two drugs improved progression-free survival by 83% over standard-of-care regimens such as daratumumab-pomalidomide-dexamethasone or daratumumab-bortezomib-dexamethasone. The regimen also reduced overall mortality risk by 54% compared with control treatments.
J&J presented these findings at the American Society of Hematology meeting in December 2025. According to Makary, “Within hours of the trial results being published,” he said in a news release that month, “FDA leaders read the study, consulted with internal experts, and the following day contacted the company to discuss a national priority voucher.”
Since its introduction in June 2025, only two other drugs have been approved under the CNPV program: USAntibiotics’ generic version of Augmentin XR in December last year and Boehringer Ingelheim’s lung cancer drug Hernexeos last month.
However, not all therapies fast-tracked through this process are approved. In February this year, Disc Medicine’s bitopertin—selected for CNPV review—was rejected due to questions about efficacy raised by Vinay Prasad, head biologics authority.
The CNPV initiative itself has drawn scrutiny from lawmakers. Rep. Jake Auchincloss of Massachusetts criticized it for lacking congressional authorization and noted that disclosures were still pending for eight senior FDA reviewers.
