FDA - Food and Drug Administration
12/15/2025 | Press release | Distributed by Public on 12/15/2025 09:07
December 15, 2025 - FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results
For Immediate Release: December 15, 2025
The U.S. Food and Drug Administration today awarded a national priority voucher to teclistamab in combination with daratumumab for relapsed/refractory multiple myeloma. This brings the total number of products receiving an award under the Commissioner's National Priority Voucher pilot program to 16.
"We're on a mission to deliver more cures and meaningful treatments to the American people. This means proactively identifying potentially transformative therapies," said FDA Commissioner Marty Makary, M.D., M.P.H. "Within hours of the trial results being publishedExternal Link Disclaimer in the American Society of Hematology conference program, FDA leaders read the study, consulted with internal experts, and the following day contacted the company to discuss a national priority voucher. When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly."
In Phase 3 clinical trial data released November 24, Tec-Dara showed significant improvements over the standard of care in both progression-free survival and overall survival among patients previously treated with one to three prior lines of therapy. At three years, more than 80% of Tec-Dara recipients remained free of progression. These results were also publishedExternal Link Disclaimer in the New England Journal of Medicine on December 9.
The CNPV pilot program is designed to accelerate the review of products with the potential to address one or more of the following key national priorities: addressing a U.S. public health crisis, delivering more innovative cures for the American people, addressing a large unmet medical need, promoting domestic drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency, and increasing affordability. Voucher recipients receive enhanced communications with review staff throughout the development process, and review decisions are targeted for completion within 1-2 months following submission of an application.
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