Johnson & Johnson’s Tecvayli Combo Wins FDA National Priority Voucher

Johnson & Johnson’s Tecvayli (teclistamab-cqyv), used in combination with daratumumab to treat relapsed or refractory multiple myeloma, has received FDA’s latest national priority voucher, becoming the 16th therapy chosen under the Commissioner’s National Priority Voucher (CNPV) pilot program (1).

What is the regulatory rationale behind the Commissioner’s National Priority Voucher Program?

The program offers an "unprecedented opportunity to reduce drug and biological product application or efficacy supplement review times from 10-12 months to just 1-2 months" (2,3). FDA Commissioner Marty Makary, MD, MPH, championed this effort, calling it a “common-sense approach” that harnesses a "tumor board style" discussion to deliver "more cures and meaningful treatments to the American public” (4). However, experts in public health and regulatory policy (5-8), as well as several industry experts who we spoke with, warn that this acceleration may come at the expense of established safety standards and fiscal responsibility.

The move follows the recent release of data from the Phase III MajesTEC-3 trial (NCT05083169), which showed the Tecvayli combination produced significant survival improvements after three years compared to standard of care among patients with relapsed or refractory disease (9,10).

“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, MD, MPH, said in a press release. “Within hours of the trial results being published 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”(1).

What is tecvayli’s mechanism of action in multiple myeloma

• Tecvayli is an off-the-shelf bispecific T cell–engaging antibody that attaches to the CD3 receptor on T cells and the B-cell maturation antigen expressed on multiple myeloma cells and some healthy B-lineage cells.
• Tecvayli subsequently activates T cells, which leads to the release of proinflammatory cytokines and in the lysis of multiple myeloma cells (11).

What were the trial design and study population of the MajesTEC-3 trial?

The randomized MajesTEC-3 trial compared the safety and efficacy of Tecvayli plus daratumumab vs. investigator’s choice of daratumumab and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients with relapsed/refractory multiple myeloma previously administered one to three lines of therapy.

• The trial’s primary endpoint is progression-free survival (PFS) with secondary endpoints that include complete response (CR) or better, overall response rate, minimal residual disease-negativity, overall survival, time to worsening of symptoms, and safety.
• Investigators enrolled 587 patients, with 291 patients randomly assigned to receive Tecvayli plus daratumumab and 296 patients randomly assigned to receive standard of care.

What were MajesTEC-3 efficacy and safety outcomes?

Trial results published by The New England Journal of Medicine show were mostly positive (Figure 1).

However, adverse event rates were higher in the Tecvayli combination arm (Figure 2).

• In terms of safety, serious adverse events (AEs) were reported by 70.7% of the patients in the Tecvayli cohort compared to 62.4% in the DPd/DVd cohort.
• Death associated with an AE occurred in 7.1% of patients in the Tecvayli cohort versus 5.9% in the DPd or DVd group.

“With these data, we are entering a new era in treating multiple myeloma with the first bispecific combination to demonstrate superior overall survival as early as second line. Alongside the other transformational therapies in our leading portfolio, we can offer patients optimal outcomes at any stage of disease – bringing us closer to our ultimate ambition to find a cure,” Sen Zhuang, MD, vice president, Oncology Clinical Research, Johnson & Johnson Innovative Medicine, said in a press release. “With Tecvayli plus Darzalex Faspro we have the potential to set a new standard of care once again for this disease. We continue to explore how regimens with our bispecifics portfolio can redefine the future for patients”(8).

Which drugs have been named to the Commissioner’s National Priority Voucher (CNPV) program?

Tecvayli joins 15 other therapies that have been added to the CNPV program. The other drugs granted vouchers to date are:

• Hernexeos (zongertinib) for HER2 lung cancer
• Sirturo (bedaquiline) for drug-resistant tuberculosis in young children
• Jemperli (dostarlimab) for rectal cancer
• Casgevy for sickle cell disease
• Orforglipron for obesity and related health conditions
• Wegovy for obesity and related health conditions
• Pergoveris for infertility
• Teplizumab for Type I diabetes
• Cytisinicline for nicotine vaping addiction
• DB-OTO for deafness
• Cenegermin-bkbj for blindness
• RMC-6236 for pancreatic cancer
• Bitopertin for porphyria
• Ketamine for domestic manufacturing of a critical drug for general anesthesia
• Augmentin XR for domestic manufacturing of a common antibiotic

Last week, Augmentin XR became the first drug approved as part of the program.

"Over the last few decades, America lost control of supply chains for key medicines we depend on. That chapter is over, we’re entering a new era of manufacturing here at home,” Makary said of last week’s approval. "This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security"(13).

References

1. FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results. News release. FDA. December 15, 2025. Accessed December 15, 2025. https://www.fda.gov/news-events/press-announcements/fda-proactively-awards-national-priority-voucher-based-strong-phase-3-study-results

2. FDA. Commissioner's National Priority Voucher (CNPV) Pilot Program. Accessed Nov 18, 2025.

3. FDA. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. Press Release. June 17, 2025.

4. FDA. FAQs: Commissioner’s National Priority Voucher Pilot Program. Accessed Nov 18, 2025.

5. Doctors for America. FDA Commissioner’s National Priority Vouchers Will Endanger Americans. Press Release. June 20, 2025.

6. Eglovitchm, J. Questions Remain as FDA Opens Submissions for New Priority Voucher Program. RAPS.org. July 24, 2025.

7. Emond, S; Ollendorf, D. How to Make One Line in the FDA Commissioner's New Drug Review Program Into a Force for Affordable Access for Patients. Health Aff Sch. 2025;3(10):qxaf182.

8. Dorsey, D; Holland, S. A Tale of Three Vouchers. BHFS.com. Sept 29, 2025.

9. Johnson & Johnson. Unprecedented results from the Phase 3 MajesTEC-3 study support Tecvayli plus Darzalex Faspro ® as a potential standard of care as early as second line for patients with relapsed/refractory multiple myeloma. News release. December 12, 2025.

10. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). ClinicalTrials.gov. Accessed December 15, 2025.

11. Kumar SK, Callander NS, Adekola K, et al. Multiple myeloma, version 3.2021, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2020;18(12):1685-1717. 

12. Costa L., et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med 2025.

13. First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity U.S. Food and Drug Administration. December 9, 2025. Accessed December 15, 2025.