Teclistamab/Daratumumab Earns FDA Priority Voucher for R/R Myeloma

The FDA has awarded a national priority voucher to the supplemental biologics license application (sBLA) of teclistamab-cqyv (Tecvayli) plus daratumumab and hyaluronidase-fihj (subcutaneous daratumumab; Darzalex Faspro) (Tec-Dara) for relapsed/refractory (R/R) multiple myeloma.^1,2

Landmark results from the phase 3 MajesTEC-3 trial (NCT05083169), recently presented at the 2025 American Society of Hematology (ASH) Annual Meeting and simultaneously published in The New England Journal of Medicine, supported the FDA’s decision and sBLA submission for the combination.^2–4 In the trial, Tec-Dara demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) as well as superior responses vs standard of care (SOC) after 3 years.

Specifically, among 587 patients with R/R myeloma, treatment with the combination over 36 months yielded an 83.4% reduction in the risk of progression or death compared with 29.7% with SOC treatment (HR, 0.17; 95% CI, 0.12–0.23; P <.0001). The respective 36-month OS rates were 83.3% and 65.0%, and OS data show a favorable trend toward Tec-Dara across all prespecified subgroups.

Those treated with Tec-Dara also had higher odds of complete response (OR, 9.56; 95% CI, 6.47–14.14), overall response (OR, 2.65; 95% CI, 1.68–4.18), and minimal residual disease (MRD) negativity (OR, 6.78; 95% CI, 4.53–10.15) than those treated with SOC.

Regarding safety, the Tec-Dara regimen demonstrated an adverse event (AE) profile largely comparable with standard of care. Both arms saw similar rates of grades 3 or 4 treatment-emergent AEs (95.1%, Tec-Dara; 96.6%, SOC), primarily attributable to cytopenia and infection. In the Tec-Dara and SOC arms, AEs resulted in death in 7.1% and 5.9%, respectively.

About Tec-Dara in Myeloma

Following the FDA’s accelerated approval of teclistamab in 2022 for treatment of adults with R/R myeloma, the series of MajesTEC trials have been launched to explore the potential of the bispecific T-cell engager antibody as combination therapy. Subcutaneous daratumumab, an anti-CD38 monoclonal antibody, initially received FDA approval in 2020 and is approved for 11 myeloma indications.

Previously, the FDA granted Tec-Dara breakthrough therapy designation.¹ With its clinically meaningful improvements, Tec-Dara is poised to enhance both survival outcomes and quality of life as early as the second line. This latest recognition, issued proactively under the FDA’s new Commissioner’s National Priority Voucher (CNPV) pilot program, makes the combination 1 of only 16 recipients to date and will enable expedited review and potentially delivery of this promising combination to patients.

“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, in a news release.² “Within hours of the trial results being published in the [ASH] 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.”

About the CNPV Program

Announced in June 2025, the FDA’s CNPV program introduces a new accelerated regulatory pathway for therapeutic products with the potential to address key US health priorities.⁵ These priorities include significant unmet medical needs, national public health crises, delivery of innovative cures, promotion of domestic drug development and manufacturing, and improved affordability.

Key benefits of the voucher include increased engagement with the FDA and rolling review of the drug or biological product application, reducing review timelines from the traditional 10 to 12 months to as little as 1 to 2 months. Additionally, the program incorporates a multidisciplinary, collaborative tumor board-style review process to help facilitate approvals.

About the MajesTEC-3 Trial

The phase 3 MajesTEC-3 trial is a global, randomized study evaluating the efficacy and safety of Tec-Dara vs standard-of-care daratumumab plus dexamethasone and investigator’s choice of pomalidomide (Pomalyst; DPd) or bortezomib (Velcade; DVd) in patients with R/R myeloma who have received 1 to 3 prior lines of therapy.⁶ As of the most recent trial report, a total of 587 patients have been enrolled and randomized to receive either Tec-Dara (n = 291) or SOC DPd or DVd (n = 296).

REFERENCES

1. Tecvayli® plus Darzalex Faspro® combination selected for commissioner’s National Priority Voucher Pilot Program. News release. Johnson & Johnson. December 15, 2025. Accessed December 16, 2025. https://tinyurl.com/3kdvybyv

2. FDA proactively awards National Priority Voucher based on strong phase 3 study results. News release. US FDA. December 15, 2025. Accessed December 16, 2025. https://tinyurl.com/b9d3ewat

3. 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. Johnson & Johnson. December 9, 2025. Accessed December 16, 2025. https://tinyurl.com/yjxk3uxu

4. Costa LJ, Bahlis NJ, Perrot A, et al. Teclistamab plus daratumumab in relapsed or refractory multiple myeloma. N Eng J Med. Published online December 9, 2025. doi:10.1056/nejmoa2514663

5. Commissioner's National Priority Voucher (CNPV) pilot program. US FDA. Updated November 6, 2025. Accessed December 16, 2025. https://tinyurl.com/3wyms88f

6. 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. Updated December 5, 2025. Accessed December 16, 2025. https://www.clinicaltrials.gov/study/NCT05083169