Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration has awarded a National Priority Voucher to teclistamab in combination with daratumumab, underscoring the clinical importance of this regimen for patients with relapsed or refractory multiple myeloma (RRMM). The announcement follows unprecedented results from the Phase 3 MajesTEC-3 trial, which Johnson & Johnson says support TECVAYLI® (teclistamab) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as a potential new standard of care as early as second-line therapy.
What the FDA’s National Priority Voucher Means
The National Priority Voucher is part of an FDA pilot program designed to accelerate regulatory review for therapies that demonstrate exceptional promise in addressing serious diseases and unmet medical needs. Receiving this voucher signals that the agency views the teclistamab–daratumumab combination as having the potential to meaningfully change clinical practice. The voucher allows for a significantly shortened FDA review timeline, helping bring impactful treatments to patients faster.
MajesTEC-3: A Pivotal Phase 3 Study
The FDA’s decision is grounded in the strength of data from MajesTEC-3 (NCT05083169), a global, randomized Phase 3 trial evaluating TECVAYLI plus DARZALEX FASPRO versus established daratumumab-based standard regimens in patients with relapsed or refractory multiple myeloma who had received prior therapy.
According to Johnson & Johnson, MajesTEC-3 delivered unprecedented efficacy outcomes in this treatment setting. The combination demonstrated marked improvements in progression-free survival, deep and durable responses, and a higher likelihood of achieving meaningful disease control compared with standard options. These benefits were observed in a population where outcomes typically decline rapidly with each subsequent line of therapy.
Why This Combination Stands Out
Teclistamab is a bispecific T-cell–engaging antibody that targets BCMA on myeloma cells and CD3 on T cells, redirecting the patient’s immune system to attack malignant plasma cells. Daratumumab, a CD38-directed monoclonal antibody, is a cornerstone therapy in multiple myeloma with a well-established efficacy and safety profile.
By combining targeted immune redirection with a proven backbone therapy, TECVAYLI plus DARZALEX FASPRO offers a complementary, immune-based approach that goes beyond incremental benefit. The MajesTEC-3 results suggest this strategy can deliver deeper and more durable responses earlier in the disease course.
Moving Toward Earlier Lines of Therapy
Historically, bispecific antibodies and other advanced immunotherapies have been reserved for heavily pretreated patients. The MajesTEC-3 data challenge that paradigm. Johnson & Johnson has emphasized that the magnitude and consistency of benefit seen in the trial support positioning the combination as early as second line, potentially reshaping treatment algorithms for relapsed multiple myeloma.
If adopted into practice, this shift could allow patients to receive highly effective immune-based therapy at a stage when they are more likely to tolerate treatment and derive long-term benefit.
Maria-Victoria Mateos, MD, PhD, Consultant Physician in Hematology at the University Hospital of Salamanca, said the combination of TECVAYLI® and DARZALEX FASPRO® has the potential to change the standard of care in relapsed or refractory multiple myeloma, offering strong efficacy, a manageable safety profile, and suitability for outpatient use as early as second-line therapy.
Mateos added that by simultaneously targeting BCMA and CD38, the regimen uniquely primes and activates the immune system, translating into extended progression-free and overall survival compared with current standard treatments.
Sen Zhuang, MD, Vice President, Oncology Clinical Research at Johnson & Johnson Innovative Medicine, said the data signal a new era in multiple myeloma treatment, describing TECVAYLI® plus DARZALEX FASPRO® as the first bispecific combination to demonstrate superior overall survival in earlier lines of therapy, with the potential to set a new standard of care once again.
Implications for Patients and Doctors
Relapsed or refractory multiple myeloma remains an area of high unmet need, with many patients experiencing diminishing responses and shorter remissions over time. The FDA’s National Priority Voucher award, combined with the compelling MajesTEC-3 results, highlights the potential of TECVAYLI plus DARZALEX FASPRO to raise the bar for efficacy in this setting.
As regulatory review progresses under the accelerated framework, clinicians and patients alike will be watching closely. If approved, this combination could represent one of the most significant advances in multiple myeloma care in recent years, offering a new, immune-driven standard earlier in the treatment journey.
References
FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results, 15 December 2025, https://www.fda.gov/news-events/press-announcements/fda-proactively-awards-national-priority-voucher-based-strong-phase-3-study-results
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, 09 December 2025, https://www.jnj.com/media-center/press-releases/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
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 ID NCT05083169, https://clinicaltrials.gov/study/NCT05083169