FDA Grants Approval to Teclistamab Combo in RRMM

The FDA granted approval to teclistamab-cqyv (Tecvayli) in combination with daratumumab hyaluronidase-fihj as a treatment for adults with relapsed/refractory multiple myeloma after at least 1 prior line of therapy, according to a release from the agnecy.¹

The FDA approved this regimen as part of its Commissioner’s National Priority Voucher (CNPV) pilot program. The agency previously awarded a national priority voucher to the teclistamab-based regimen in December 2025.²

“The FDA is now proactively moving to cut idle time to accelerate meaningful treatments for the American people. Multiple myeloma is notoriously challenging to treat,” Marty Makary, MD, PhD, the commissioner of the FDA, stated in the release.¹ “When we saw the most impressive second-line myeloma trial results in history, we acted quickly to bring this finding to everyday Americans wrestling with the disease.”

Supporting data for the approval came from the phase 3 MajesTEC-3 trial (NCT05083169) evaluating the teclistamab combination vs subcutaneous daratumumab and dexamethasone plus pomalidomide (Pomalyst) or bortezomib (Velcade). Data presented at the 2025 American Society of Hematology (ASH) Annual Meeting and Exposition revealed a 36-month overall survival (OS) rate of 83.3% in the teclistamab arm vs 65.0% in the comparator arm (HR, 0.46; 95% CI, 0.32-0.65; P <.0001).³ Additionally, the median progression-free survival (PFS) was not reached vs 18.1 months in each arm (HR, 0.17; 95% CI, 0.12-0.23; P <.0001).

The safety profile of teclistamab/daratumumab in the trial showed that all instances of cytokine release syndrome (CRS) were grades 1 (44.2%) and 2 (15.9%); all events resolved. The most common hematologic adverse effect in the teclistamab and comparator arm was neutropenia (78.4% vs 82.8%).

“If approved, the [teclistamab/daratumumab] combination, which is highly effective—[with] the best 3-year PFS that we’ve seen to date—offers another option in the myeloma armamentarium,” Surbhi Sidana, MD, associate professor of medicine and lead of the Myeloma CAR-T/Immunotherapy Program at Stanford University in California, stated in an interview with CancerNetwork^® ahead of the approval. “We want to be patient centric. This [approval] gives our patients options.”

References

1. FDA grants third approval under the National Priority Voucher Program. News release. FDA. March 5, 2026. Accessed March 5, 2026. https://tinyurl.com/45hhbpau
2. FDA proactively awards national priority voucher based on strong phase 3 study results. News release. FDA. December 15, 2025. Accessed March 5, 2026. https://tinyurl.com/2x9uvufa
3. Mateos MV, Bahlis N, Perrot A, et al. 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. Blood. 2025;146(suppl 2):LBA-6. doi:10.1182/blood-2025-LBA-6