La FDA approuve l’association Tecvayli–Darzalex Faspro et accepte la NDA d’iberdomide dans le myélome en rechute ou réfractaire
La FDA a approuvé Tecvayli en association avec Darzalex Faspro chez des adultes atteints de myélome multiple en rechute ou réfractaire après au moins une ligne de traitement, et a accepté une demande d’autorisation (NDA) pour iberdomide en combinaison avec daratumumab et dexaméthasone. La date PDUFA est fixée au 17 août 2026.
The U.S. Food and Drug Administration approved Tecvayli (teclistamab) in combination with Darzalex Faspro (daratumumab hyaluronidase-fihj) 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 on March 5, 2026. The approval expands use of Tecvayli beyond its earlier accelerated approval and converts that authorization to traditional approval for use as a single agent in adults 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.
The approval was based on results from MajesTEC-3, a randomized open-label multi-center trial that evaluated Tecvayli plus Darzalex Faspro compared with investigator's choice control therapy. A total of 587 patients were randomized in the study. Of those, 291 received Tecvayli plus Darzalex Faspro. The remaining 296 received control therapy that included Darzalex Faspro plus either Pomalyst (pomalidomide) and dexamethasone or Velcade (bortezomib) and dexamethasone.
Median progression-free survival was not reached in the Tecvayli plus Darzalex Faspro arm. Median progression-free survival was 18.1 months in the control group. The combination therapy lowered the risk of disease progression or death compared with control therapy. Median overall survival was not reached in either study arm.
The approval was part of the FDA Commissioner's National Priority Review Voucher pilot program. The review was conducted under several FDA programs designed to speed development and evaluation of treatments for serious conditions, including Project Orbis. Tecvayli received breakthrough designation, orphan drug designation and priority review.
In a separate regulatory action, the FDA has accepted a New Drug Application for iberdomide combined with standard treatment (daratumumab plus dexamethasone) in patients with relapsed or refractory multiple myeloma. Iberdomide is part of an investigational, new class of medicines called cereblon E3 ligase modulator (CELMoD) agents. The FDA has granted a Prescription Drug User Fee Act date of August 17, 2026 for this indication.
The filing was based on results from a planned analysis of minimal residual disease negativity rates in the Phase 3 EXCALIBER-RRMM study evaluating iberdomide as a treatment for patients with relapsed or refractory multiple myeloma. The EXCALIBER-RRMM trial is ongoing and patients continue to be evaluated for progression-free survival. The FDA granted Breakthrough Therapy designation for iberdomide based on these data.
EXCALIBER-RRMM (NCT04975997) is a Phase 3, multicenter, two-stage, randomized, open-label study evaluating the efficacy and safety of iberdomide in combination with daratumumab and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma. The study is designed to assess dual-primary endpoints of minimal residual disease negativity and progression-free survival, with additional secondary endpoints including overall survival, overall response rate, duration of response, time to progression, time to next treatment, and health-related quality of life. In Stage 2, approximately 664 patients were randomized to receive either iberdomide plus daratumumab and dexamethasone or daratumumab, bortezomib, and dexamethasone.
The prescribing information for Tecvayli includes a boxed warning for life threatening or fatal cytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity. Because of these risks, Tecvayli is available only through a restricted Risk Evaluation and Mitigation Strategy program called the Tecvayli-Talvey REMS. The most common side effects of Tecvayli plus Darzalex Faspro included hypogammaglobulinemia, upper respiratory tract infection, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis and decreased weight.