FDA Awards National Priority Voucher to Teclistamab Plus Daratumumab in Relapsed/Refractory Multiple Myeloma

The FDA awarded a national priority voucher to teclistamab-cqyv (Tecvayli; Johnson & Johnson) in combination with daratumumab (Darzalex; Johnson & Johnson) for the treatment of relapsed/refractory multiple myeloma. According to a news release from the agency, this action brings the total number of products receiving an award under the Commissioner’s National Priority Voucher (CNPV) pilot program to 16.¹

What is the CNPV Pilot Program?

The CNPV pilot program, which was announced in June 2025, offers an opportunity to reduce drug and biological product application or efficacy supplement (ES) review times from 10 to 12 months to just 1 to 2 months, according to the FDA. The program utilizes a collaborative tumor board-style review process to accelerate approvals for companies aligned with critical US national health priorities. Those selected for the program are issued a voucher entitling the company to benefits, including enhanced communications and a rolling review to allow for a shortened review time.¹

The CNPV pilot program reflects the FDA's broader commitment to create more efficient approval processes and modernize regulatory frameworks for greater agility to meet emerging public health needs. Teclistamab joins 15 other therapies that have been added to the CNPV program.¹ The other drugs granted vouchers to date are¹:

• Zongertinib (Hernexeos; Boehringer Ingelheim) for HER2 lung cancer;
• Bedaquiline (Sirturo; Janssen Biotech) for drug-resistant tuberculosis in young children;
• Dostarlimab (Jemperli; GSK) for rectal cancer;
• Exagamglogene autotemcel (Casgevy; Vertex Pharmaceuticals) for sickle cell disease;
• Orforglipron (Eli Lilly & Co) for obesity and related health conditions;
• Semaglutide (Wegovy; Novo Nordisk) for obesity and related health conditions;
• Follitropin alfa/lutropin alfa (Pergoveris; Merck) for infertility;
• Teplizumab (Tzield; Sanofi) for type 1 diabetes;
• Cytisinicline (Achieve Life Sciences) for nicotine vaping addiction;
• DB-OTO (Regeneron) for deafness;
• Cenegermin-bkbj (Oxervate; Dompé farmaceutici SpA) for blindness;
• Daraxonrasib (RMC-6236; Revolution Medicines) for pancreatic cancer;
• Bitopertin (DISC-1459; Disc Medicine) for porphyria;
• Ketamine for domestic manufacturing of a critical drug for general anesthesia; and
• Augmentin XR for domestic manufacturing of a common antibiotic

What Supported This Action?

The action follows the recent release of data from the phase 3 MajesTEC-3 clinical trial (NCT05083169)³, a randomized study that compared the safety and efficacy of subcutaneous teclistamab plus daratumumab (Tec-Dara) versus daratumumab, pomalidomide (Pomalyst; Bristol Myers Squibb), and dexamethasone (DPd) or daratumumab, bortezomib (Velcad; Takeda Oncology), and dexamethasone (DVd). A total of 587 patients with relapsed/refractory multiple myeloma who previously received 1 to 3 prior lines of therapy were randomly assigned to receive Tec-Dara (n = 291), DPd, or DVd (n = 296 between both groups). Findings were presented at the American Society of Hematology (ASH) 2025 Annual Meeting & Exposition⁴ and simultaneously published in New England Journal of Medicine.⁵

At a median of about 34.5 months, progression-free survival (PFS) was significantly longer with Tec-Dara than with either DPd or DVd. The estimated 36-month PFS was approximately 83.4% for those treated with Tec-Dara compared with 29.7% in the DPd or DVd group (HR, 0.17 [95% CI, 0.12–0.23]; P < .001). Additionally, more patients in the Tec-Dara group than in the DPd or DVd group had a complete response or better (81.8% vs 32.1%, respectively), an overall response (89.0% vs 75.3%), and minimal residual disease negativity (10^-5; 58.4% vs 17.1%; P < .001 for all comparisons). Serious adverse events (AEs) occurred in about 70.7% of the patients in the Tec-Dara group and in 62.4% of those in the DPd or DVd group. Death related to AEs occurred in 7.1% and 5.9% of these respective groups.^4,5

“We’re on a mission to deliver more cures and meaningful treatments to the American people. This means proactively identifying potentially transformative therapies,” Marty Makary, MD, MPH, FDA Commissioner, said in the news release reporting the announcement. “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

REFERENCES

1. US Food & Drug Administration. FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results. News release. December 15, 2025. Accessed December 16, 2025. https://www.fda.gov/news-events/press-announcements/fda-proactively-awards-national-priority-voucher-based-strong-phase-3-study-results

2. US Food & Drug Administration. Commissioner's National Priority Voucher (CNPV) Pilot Program. Accessed December 16, 2025. https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program

3. 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 identifier: NCT05083169. Updated December 5, 2025. Accessed December 16, 2025. https://clinicaltrials.gov/study/NCT05083169

4. Halpern L. Teclistamab Plus Daratumumab and Hyaluronidase Improves Survival in Relapsed, Refractory MM. Pharmacy Times. December 9, 2025. Accessed December 16, 2025. https://www.pharmacytimes.com/view/teclistamab-cqyv-with-daratumumab-and-hyaluronidase-fihj-improves-survival-in-relapsed-refractory-mm

5. Costa LJ, Bahlis NJ, Perrot A, et al; MajesTEC-3 Trial Investigators. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. Published December 9, 2025. doi:10.1056/NEJMoa2514663