TALVEY (talquetamab-tgvs)
TALVEY is indicated for the treatment of Multiple Myeloma.
How TALVEY Works
Talquetamab-tgvs is a bispecific T-cell engaging antibody that binds to the CD3 receptor on the surface of T-cells and the GPRC5D receptor on the surface of multiple myeloma cells. This dual binding activates the T-cells, causing the release of proinflammatory cytokines and the subsequent lysis of the multiple myeloma cells. While GPRC5D is expressed on malignant cells, it is also found on non-malignant plasma cells and healthy epithelial cells in the skin and tongue.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-08-09
- Patent Cliff
- 2035
- Revenue
- $140M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TALVEY Approval History
What TALVEY Treats
1 indicationsTALVEY is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
TALVEY 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 TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.5 ) , Warnings and Precautions (5.1) ] . Neurologic toxicity, including...
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 TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.5 ) , Warnings and Precautions (5.1) ] . Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life threatening or fatal reactions, can occur with TALVEY. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment and treat promptly. Withhold or permanently discontinue TALVEY based on severity [see Dosage and Administration (2.5) , Warnings and Precautions (5.2) ] . Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (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 TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity. ( 2.2 , 2.5 , 5.1 ) Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur in patients receiving TALVEY. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold or permanently discontinue TALVEY based on severity. ( 2.5 , 5.2 ) TALVEY is availa
TALVEY 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 TALVEY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TALVEY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TALVEY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
30 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) |
| NCT05849610 GEM-TECTAL | GEM-TECTAL | Ph 2 | active not recruiting | Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma |
| NCT04634552 MonumenTAL-1 | CR108920 TALMMY1001-PT3, 2017-002400-26 | Ph 2 | recruiting | A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT06500884 Talisman | 64407564MMY2006 2023-506260-14-00 | Ph 2 | recruiting | A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events |
| NCT05050097 MonumenTAL-2 | CR108946 64407564MMY1004, 2020-004502-55 | Ph 1 | active not recruiting | A Study of Talquetamab With Other Anticancer Therapies in Participants With 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 |
| NCT03399799 MonumenTAL-1 | CR108404 64407564MMY1001, 2017-002400-26 | Ph 1 | active not recruiting | Dose Escalation Study of Talquetamab in 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 |
| NCT06550895 MonumenTAL-8 | 64407564MMY2008 2023-507989-76-00 | Ph 2 | active not recruiting | A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk 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 |
| NCT05972135 | MM165 | Ph 2 | recruiting | Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma |
| 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. |
| NCT07032714 MAGENTA | 25-320 | Ph 1 | recruiting | Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma |
| NCT05455320 MonumenTAL-3 | CR109082 64407564MMY3002, 2021-000202-22 | Ph 3 | active not recruiting | A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment |
| 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 |
| NCT06348108 | 232514 NCI-2024-01992 | Ph 1 | recruiting | Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory 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 |
| NCT06066346 | 23-072 | Ph 2 | recruiting | A Study of Talquetamab for People With Multiple Myeloma Who Have Received BCMA CAR T-Cell Therapy |
| NCT03601078 KarMMa-2 | BB2121-MM-002 U1111-1216-4209, 2023-505183-10 | Ph 2 | completed | An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma |
| 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) |
| 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 |
| NCT07093554 | PRO00055520 | Ph 1 | recruiting | Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma |
| NCT05695508 HD10/DSMMXX | GMMG-HD10/DSMM-XX | Ph 2 | recruiting | GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 |
| NCT06827860 | STUDY-24-00798 64407564MMY2004 | Ph 2 | recruiting | Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse |
| NCT04773522 | CR108930 64407564MMY1003 | Ph 1 | completed | A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma |
| NCT06572605 | 23931 NCI-2024-06707, 23931 | Ph 1, Ph 2 | recruiting | External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease |
| NCT06461988 | IRB-73317 NCI-2024-06734 | Ph 2 | recruiting | Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma |
| NCT05461209 MonumenTAL-5 | CR109235 64407564MMY3008, 2022-001442-38 | Ph 3 | withdrawn | A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory 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.
TALVEY FDA Label Details
Indications & Usage
FDA Label (PDF)TALVEY 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 TALVEY. Initiate TALVEY treatment with step-up dosing to reduce...
Pro Intelligence Preview
Deep insights for TALVEY
Revenue Insights
- • Q4-2025: $140M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • Generic/biosimilar risk
Trial Analysis
- • 30 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