Johnson & Johnson has received a Commissioner’s National Priority Voucher from the U.S. Food and Drug Administration (FDA) for its investigational combination therapy of Tecvayli and Darzalex, intended for patients with relapsed or refractory multiple myeloma. The company was granted the voucher without submitting an application.
The FDA’s decision followed data from the Phase III MajesTEC-3 study, which was presented at the American Society of Hematology’s annual meeting earlier this month. The study found that patients treated with Tecvayli plus Darzalex experienced an 83% improvement in progression-free survival at a median follow-up of 34.5 months compared to those who received standard therapies. Overall survival rates also favored the combination treatment, with 83.3% of patients alive at 36 months versus 65% in the control group.
“Within hours of the trial results being published, FDA leaders read the study, consulted with internal experts, and the following day contacted the company to discuss a national priority voucher,” said FDA Commissioner Marty Makary in a prepared statement on Monday. This action is part of what Makary described as “the agency’s mission to accelerate promising therapies.”
“When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly,” Makary added.
Johnson & Johnson becomes the sixteenth recipient of such a voucher since the program began in June. The initiative grants vouchers to companies developing products that address federal priorities such as significant medical needs, domestic manufacturing enhancement, or efforts to reduce drug prices under policies like President Donald Trump’s Most Favored Nation scheme.
A national priority voucher allows companies to shorten FDA review times for their drugs from about 10–12 months down to one or two months.
Previous recipients include Sanofi for its type 1 diabetes drug Tzield; Regeneron for its gene therapy DB-OTO targeting hereditary deafness; Revolution Medicines for RMC-6236 aimed at pancreatic cancer; USAntibiotics’ amoxicillin formulation Augmentin XR—recently receiving approval while supporting U.S.-based manufacturing—and others like Novo Nordisk’s Wegovy and Eli Lilly’s orforglipron addressing obesity, as well as Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy for sickle cell disease.
