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Bcmaxcd3 (TECLISTAMAB)
Teclistamab-cqyv activates T-cells by binding to CD3 and BCMA, leading to the lysis of multiple myeloma cells.
Teclistamab-cqyv, marketed by Johnson & Johnson, is a bispecific antibody targeting CD3 and BCMA for the treatment of relapsed or refractory multiple myeloma, positioning it in a competitive landscape with several other drugs targeting similar mechanisms. Its key strength lies in its ability to activate T-cells and induce lysis of multiple myeloma cells, offering a potent combination therapy option. The primary risk is the expiration of its key composition patent in 2028, which could lead to increased competition from generics and biosimilars.
At a glance
| Generic name | TECLISTAMAB |
|---|---|
| Sponsor | Johnson & Johnson |
| Target | CD3, BCMA |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2022 |
| Annual revenue | 400 |
Mechanism of action
Teclistamab-cqyv is a bispecific antibody that targets both the CD3 receptor on T-cells and BCMA on multiple myeloma cells. When it binds to these receptors, it activates T-cells, causing them to release proinflammatory cytokines and destroy the cancer cells.
Approved indications
- Relapsed or Refractory Multiple Myeloma (Combination Therapy)
- Relapsed or Refractory Multiple Myeloma (Monotherapy)
Boxed warnings
- WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.5) and Warnings and Precautions (5.1) ] . Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ] . Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS [see Warnings and Precautions (5.3) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.5 , 5.1 ) Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity. ( 2.5 , 5.2 ) TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS). ( 5.3 )
Common side effects
- pyrexia
- cytokine release syndrome
- musculoskeletal pain
- injection site reaction
- fatigue
- upper respiratory tract infection
- nausea
- headache
- pneumonia
- diarrhea
- hypogammaglobulinemia
- cough
Drug interactions
- CYP substrates
Key clinical trials
- Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma (PHASE1)
- Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment (PHASE1,PHASE2)
- Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse (PHASE2)
- Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma (PHASE1)
- Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (PHASE3)
- A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma (PHASE3)
- 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 (PHASE3)
- Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bcmaxcd3 CI brief — competitive landscape report
- Bcmaxcd3 updates RSS · CI watch RSS
- Johnson & Johnson portfolio CI