On Monday, December 15, Johnson & Johnson announced via press release that the U.S. Food and Drug Administration “has selected the teclistamab MajesTEC-3 supplemental Biologics License Application (sBLA) to participate in the Commissioner’s National Priority Voucher (CNPV) Pilot Program as it aligns with the program’s priority to deliver more innovative therapies for American people.” 
 

“We’re on a mission to deliver more cures and meaningful treatments to the American people. This means proactively identifying potentially transformative therapies. Within hours of the 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,” stated FDA Commissioner Marty Makary, M.D., M.P.H. in an FDA news release.

“The sBLA is based on the Phase 3 MajesTEC-3 results, which showed TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) demonstrated a statistically significant progression-free survival (PFS) and overall survival advantage compared to standard treatment after three years in patients with relapsed/refractory multiple myeloma. These results support the combination as a potential standard of care as early as second line. The U.S. FDA is reviewing the sBLA through the Real-Time Oncology Review (RTOR) program,” according to Johnson & Johnson. 
 
Published in The New England of Medicine and presented as a late-breaking oral abstract (LBA-6) at the recently concluded American Society of Hematology (ASH) Annual Meeting, results of the MajesTEC-3 trial revealed that "patients with relapsed/refractory multiple myeloma who received a combination of teclistamab, a bispecific monoclonal antibody, and daratumumab, a CD38-directed monoclonal antibody, were 83% more likely to be alive without disease progression compared with those who received standard second-line therapies at a median of nearly 35 months of follow-up," stated ASH in a press release. 
 
According to IMF Scientific Advisory Board Member and lead study author María-Victoria Mateos, MD, PhD (University of Salamanca — Salamanca, Spain), they were "surprised by the efficacy data [and] didn’t expect such a magnitude of benefit."

"These are the best data we’ve seen in patients with R/R multiple myeloma after one line of therapy. Patients will live longer overall and with no worsening of quality of life," said Dr. Mateos. 
 
The Commissioner’s National Priority Voucher (CNPV) Pilot Program “offers an unprecedented opportunity to reduce drug and biological product application or efficacy supplement (ES) review times from 10–12 months to just 1–2 months. Announced in June 2025, this innovative program uses a collaborative tumor board-style review process to accelerate approvals for companies aligned with critical U.S. national health priorities,” states the FDA website, with the following key program benefits: 
 
    • Faster review times (10–12 months vs. 1–2 months) 
    • Enhanced communication throughout the review process 
    • Multidisciplinary team-based evaluation 
    • Potential for accelerated approval if applicable requirements are met 
    • Maintains FDA's rigorous safety and efficacy standards 
 
“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,” the FDA further said. 
 

References: 
TECVAYLI® plus DARZALEX FASPRO® combination selected for Commissioner’s National Priority Voucher Pilot program, Johnson & Johnson press release, December 15, 2025. 

FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results, FDA news release, December 15, 2025.
 
Costa LJ, Bahlis NJ, Perrot A, Nooka et al. MajesTEC-3 Trial Investigators. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2025 Dec 9. doi: 10.1056/NEJMoa2514663. 

María-Victoria Mateos, et al. Presentation ID LBA-6: Phase 3 randomized study of teclistamab plus daratumumab versus investigator’s choice of daratumumab and dexamethasone with either pomalidomide or Bortezomib (DPd/DVd) in patients (Pts) with relapsed refractory multiple myeloma (RRMM): Results of majestec-3. 67th ASH Annual Meeting Late-Breaking Abstracts Session, December 9, 2025.

Tec-Dara Combination Offers Substantial Improvement Over Standard Second-Line Therapies for Relapsed or Refractory Multiple Myeloma, American Society of Hematology press release, December 9, 2025. 
 
Commissioner's National Priority Voucher (CNPV) Pilot Program, U.S. Food and Drug Administration. November 6, 2025.