J&J’s Tecvayli and Darzalex Combo Wins FDA’s Proactive National Priority Voucher for Relapsed/Refractory Multiple Myeloma
The FDA proactively awarded a Commissioner's National Priority Voucher (CNPV) on December 15, 2025, to Johnson & Johnson's sBLA for teclistamab (Tecvayli) plus daratumumab (Darzalex Faspro) for relapsed/refractory multiple myeloma, marking the 16th recipient of the program1235.
The decision followed strong phase 3 MajesTEC-3 trial results presented at the 2025 ASH Annual Meeting, showing significant improvements in progression-free survival, overall survival, and response rates versus standard care123.
FDA Commissioner Marty Makary stated the agency contacted J&J within hours of the ASH results to discuss the voucher, aiming to expedite review from 10-12 months to 1-2 months via rolling review and multidisciplinary evaluation124.
The CNPV pilot program, launched in June 2025, targets therapies addressing unmet needs, public health crises, and innovative cures to accelerate approvals234.
J&J expressed enthusiasm for collaborating with the FDA to deliver this potentially transformational regimen quickly3.
Sources:
1. https://www.biopharmadive.com/news/tecvayli-voucher-pfizer-gilead-hiv-link-sanofi-dren/807885/
2. https://www.targetedonc.com/view/teclistamab-daratumumab-earns-fda-priority-voucher-for-r-r-myeloma
3. https://www.jnj.com/media-center/press-releases/tecvayli-plus-darzalex-faspro-combination-selected-for-commissioners-national-priority-voucher-pilot-program
4. https://www.pharmacytimes.com/view/fda-awards-national-priority-voucher-to-teclistamab-plus-daratumumab-in-relapsed-refractory-multiple-myeloma
5. https://www.fda.gov/news-events/press-announcements/fda-proactively-awards-national-priority-voucher-based-strong-phase-3-study-results