The FDA granted Johnson & Johnson a Commissioner’s National Priority Voucher in December 2025 after the combination of Darzalex and Tecvayli improved progression-free survival by 83%. The new approval is for second-line treatment of the blood cancer.
The FDA has approved Johnson & Johnson’s combination regimen of Tecvayli and Darzalex for second-line treatment of multiple myeloma.
The approval came 55 days after J&J filed its application package, the FDA said in a Thursday release. The rapid timeline was supported by a Commissioner’s National Priority Voucher (CNPV), which the regulator “proactively” granted J&J in December 2025.
“When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly,” Commissioner Marty Makary said at the time.
Tecvayli is a bispecific antibody that targets both the BCMA protein on multiple myeloma cells and CD3 receptors on T cells, enabling the immune system to better fight the cancer. Darzalex, meanwhile, seeks out and blocks the CD38 marker on cancer cells, triggering their death.
In the Phase 3 MajesTEC-3 study, combining these two mechanisms resulted in an 83% improvement in progression-free survival over controls who were treated with standard of care triplets such as daratumumab-pomalidomide-dexamethasone or daratumumab-bortezomib-dexamethasone. J&J’s drug combo also cut the risk of death from all causes by 54% versus the control treatment.
J&J presented these findings at the 2025 American Society of Hematology in December last year, after which FDA staffers moved quickly, Makary said. “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.”
First announced in June 2025, the Commissioner’s National Priority Voucher (CNPV) Program seeks to drastically speed up review timelines for companies that align with certain national priorities, such as responding to unmet medical needs or lowering drug costs in accordance with the government’s Most Favored Nation directive. Voucher holders can expect a regulatory verdict within 1–2 months, down from the typical 10–12 months.
Two other drugs have been approved under the CNPV program so far. The first came in December last year and was granted to USAntibiotics for its generic version of the antibiotic Augmentin XR. Then, last month, the FDA cleared Boehringer Ingelheim’s lung cancer therapy Hernexeos.
But being awarded a CNPV ticket doesn’t guarantee a favorable decision. In mid-February, the regulator rejected Disc Medicine’s bitopertin for the rare blood disorder erythropoietic protoporphyria. Bitopertin was selected for the CNPV program in October 2025, but in December, reports circulated that Vinay Prasad, head biologics authority, was skeptical of its efficacy.
