TECVAYLI (teclistamab-cqyv)
TECVAYLI (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for adult patients with relapsed or refractory multiple myeloma. Eligible patients must have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate, and continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
How TECVAYLI Works
Teclistamab-cqyv is a bispecific T-cell engaging antibody that binds to the CD3 receptor on T-cells and the B-cell maturation antigen (BCMA) on multiple myeloma cells. This dual binding activates T-cells and triggers the release of proinflammatory cytokines. The resulting immune response leads to the lysis of multiple myeloma cells and some healthy B-lineage cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-10-25
- Patent Cliff
- 2034
- Revenue
- $195M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TECVAYLI Approval History
What TECVAYLI Treats
1 indicationsTECVAYLI is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
TECVAYLI Boxed 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 , 2.4) and Warnings and Precautions (5.1) ] . Neurologic toxicity...
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 , 2.4) 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 with 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 (2.4) 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 , 2.4 , 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 toxi
TECVAYLI Target & Pathway
ProTarget
A protein highly expressed on malignant plasma cells in multiple myeloma. BCMA-targeted therapies, including CAR-T cells and bispecific antibodies, can eliminate myeloma cells while sparing most normal immune cells.
TECVAYLI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TECVAYLI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TECVAYLI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TECVAYLI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
38 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06993675 ROTATE | 2000038510 | Ph 2 | recruiting | Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE) |
| NCT06465316 | NCI-2024-04754 NCI-2024-04754, 10620 | Ph 1 | recruiting | Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma |
| NCT06948084 | NCI-2025-02986 NCI-2025-02986, EAA232 | Ph 2 | not yet recruiting | 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 |
| NCT07463807 | NCI-2026-01300 NCI-2026-01300, EAA242 | Ph 1, Ph 2 | not yet recruiting | 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 |
| NCT07332507 | NCI-2025-09714 NCI-2025-09714, PHI-155 | Ph 1 | not yet recruiting | Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma |
| NCT07581704 | 202601163 | Ph 1 | not yet recruiting | Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma |
| NCT07518186 TRIlogy-5 | 79635322MMY3002 | Ph 3 | not yet recruiting | A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT05849610 GEM-TECTAL | GEM-TECTAL | Ph 2 | active not recruiting | Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma |
| NCT05083169 MajesTEC-3 | CR109049 64007957MMY3001, 2020-004742-11 | Ph 3 | active not recruiting | 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 |
| NCT05338775 TRIMM-3 | CR109168 64407564MMY1005, 2021-005073-22 | Ph 1 | active not recruiting | A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma |
| NCT04108195 | CR108620 64407564MMY1002, 2019-000330-19 | Ph 1 | active not recruiting | A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma |
| NCT06577025 aMMbition | 54767414MMY2093 54767414MMY2093, 2023-505792-71-00 | Ph 2 | active not recruiting | A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma |
| NCT07258511 TRIlogy-4 | 79635322MMY3001 79635322MMY3001, 2025-522007-18-00 | Ph 3 | recruiting | A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT05552222 MajesTEC-7 | CR109237 64007957MMY3005, 2022-000909-28 | Ph 3 | recruiting | A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma |
| NCT04722146 MajesTEC-2 | CR108927 64007957MMY1004, 2020-004404-33 | Ph 1 | active not recruiting | A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma |
| NCT07030517 | 64007957MMY4007 | Ph 4 | recruiting | A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma |
| NCT05972135 | MM165 | Ph 2 | recruiting | Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma |
| NCT06649695 | EMN40/64007957AMY2002 | Ph 2 | recruiting | A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis |
| NCT07107529 | EMN37 2024-520433-76-00 | Ph 2 | recruiting | Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab. |
| NCT06425991 MajesTEC-10 | 64007957MMY1008 64007957MMY1008, 2023-508426-10-00 | Ph 1 | active not recruiting | A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT04557098 MajesTEC-1 | CR108859 TECLIMMY1001-P3, 2016-002122-36 | Ph 2 | active not recruiting | A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT05572515 MajesTEC-9 | CR109244 64007957MMY3006, 2022-000928-37 | Ph 3 | active not recruiting | A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT04696809 | CR108949 64007957MMY1002 | Ph 1, Ph 2 | active not recruiting | A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma |
| NCT05243797 MajesTEC-4 | EMN30/64007957MMY3003 | Ph 3 | recruiting | 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 |
| NCT06353022 IFm2022-01 | RC23_0267 2023-508310-41 | Ph 2 | active not recruiting | Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma |
| NCT06208150 MonumenTAL-6 | 64407564MMY3009 64407564MMY3009, 2022-502446-27-00 | Ph 3 | recruiting | A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide |
| NCT06100237 REVIVE | 20221148 | Ph 2 | recruiting | Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study) |
| NCT07105059 | 24-393 | Ph 1 | recruiting | A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma |
| NCT04586426 RedirecTT-1 | CR108901 64007957MMY1003, 2019-004124-38 | Ph 1, Ph 2 | active not recruiting | A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT04068597 | CCS1477-02 | Ph 1, Ph 2 | recruiting | Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies |
| NCT06251076 | Outpatient TEC CAPCR 23-5935, 64007957MMY4009 | Ph 4 | recruiting | Plan Development for Giving Teclistamab in the Outpatient Setting |
| NCT07110844 | AAAV8827 1452862 | Ph 2 | recruiting | Teclistamab-Daratumumab in AL Amyloidosis |
| NCT05572229 IFM2021-01 | 2022_0174 2022-001594-31 | Ph 2 | recruiting | Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma |
| NCT06588660 | RG1123948 NCI-2024-07236, 20589 | Ph 1 | terminated | ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma |
| NCT06171685 | MMRC-099 | Ph 2 | recruiting | MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM |
| NCT05469893 | 22-154 | Ph 2 | recruiting | Immuno-PRISM (PRecision Intervention Smoldering Myeloma) |
| NCT06880601 TALIM | MM0125 | Ph 2 | not yet recruiting | Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma |
| NCT06505369 TALTEC | CT number 2023-508212-38-00 | Ph 2 | recruiting | Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TECVAYLI FDA Label Details
Indications & Usage
FDA Label (PDF)TECVAYLI is indicated for the treatment of Multiple Myeloma.
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 schedu...
Pro Intelligence Preview
Deep insights for TECVAYLI
Revenue Insights
- • Q4-2025: $195M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • Generic/biosimilar risk
Trial Analysis
- • 37 total trials
- • Stage: Growth
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment