Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a Phase III study testing Tecvayli plus Darzalex in patients with relapsed or refractory multiple myeloma.
Johnson & Johnson has secured a Commissioner’s National Priority Voucher from the FDA—without even having to apply for it. The ticket covers J&J’s investigational combination of Tecvayli plus Darzalex for the treatment of relapsed or refractory multiple myeloma.
The voucher award was prompted by findings from the Phase III MajesTEC-3 study, which the pharma presented at the annual meeting of the American Society of Hematology earlier this month. Results showed an 83% improvement in progression-free survival in patients treated with the combination at a median of 34.5 months, compared to controls receiving standard therapies.
Overall survival likewise leaned strongly in favor of Tecvayli plus Darzalex, hitting 83.3% at 36 months versus 65% in controls.
“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,” FDA Commissioner Marty Makary said in a prepared statement on Monday. This proactive award, he added, is part of 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 said.
J&J is the 16th company to be awarded the national priority voucher since the program was announced in June. The vouchers are granted to companies whose products align with certain federal priorities, including addressing key medical needs, boosting domestic manufacturing and lowering drug prices in line with President Donald Trump’s Most Favored Nation scheme.
Companies can use the priority voucher to drastically shorten drug review times from the usual 10–12 months to 1–2 months.
The first batch of vouchers were handed out in October and included Sanofi’s type 1 diabetes drug Tzield, Regeneron’s investigational gene therapy DB-OTO for hereditary deafness and Revolution Medicines’ oral cancer drug RMC-6236 for pancreatic cancer. One awardee from this group, USAntibiotics’ amoxicillin formulation Augmentin XR, won the first CNPV approval earlier this month, “strengthening the U.S. drug supply chain through enhanced domestic manufacturing,” according to the regulator.
The second batch of CNPVs, awarded in November, included Novo Nordisk’s weight-loss blockbuster Wegovy and Eli Lilly’s oral obesity candidate orforglipron. Vertex Pharmaceuticals and CRISPR Therapeutics’ gene therapy Casgevy for sickle cell disease has also been given a voucher.
