FDA Approves Teclistamab Plus Daratumumab and Hyaluronidase for Previously Treated Multiple Myeloma
Clinical Summary:
-
The FDA approved teclistamab plus daratumumab and hyaluronidase for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, based on findings from the phase 3 MajesTEC-3 trial.
-
In MajesTEC-3, teclistamab plus daratumumab and hyaluronidase significantly improved progression-free survival and overall survival compared with standard daratumumab-based regimens. Median progression-free survival was not reached with the combination versus 18.1 months with investigator's choice therapy.
-
The FDA also converted the accelerated approval of teclistamab monotherapy to traditional approval for patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, reinforcing teclistamab's role across multiple treatment settings.
On March 5, 2026, the US Food and Drug Administration (FDA) approved teclistamab in combination with daratumumab and hyaluronidase for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. The approval was supported by findings from the phase 3 MajesTEC-3 trial.
In this multicenter, open-label trial, 587 patients were randomized to receive teclistamab plus daratumumab and hyaluronidase (n = 291) or investigator's choice of daratumumab and hyaluronidase, pomalidomide, and dexamethasone or daratumumab and hyaluronidase, bortezomib, and dexamethasone (n = 296). The primary end points were progression-free survival (PFS), as assessed by independent review according to International Myeloma Working Group (IMWG) 2016 criteria, and overall survival (OS). Safety was a key secondary end point.
Median PFS was not reached with teclistamab plus daratumumab and hyaluronidase compared with 18.1 months in the control arm (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12 to 0.23; P < .0001). Median OS was not reached in either treatment arm, with a significant survival benefit favoring teclistamab (HR, 0.46; 95% CI, 0.32 to 0.65; P < .0001).
The most common adverse events with teclistamab plus daratumumab and hyaluronidase included hypogammaglobulinemia, upper respiratory tract infection, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection-site reactions, fatigue, pyrexia, headache, nausea, gastroenteritis, and decreased weight.
The prescribing information includes a boxed warning for cytokine release syndrome and neurologic toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS).
The FDA also converted the accelerated approval of teclistamab monotherapy to traditional approval for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Teclistamab is available only through the Tecvayli-Talvey Risk Evaluation and Mitigation Strategy (REMS) program.
Source:
US Food and Drug Administration. FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma. Accessed on March 5, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-combination-daratumumab-hyaluronidase-fihj-relapsed-or-refractory-multiple
