Also known as: Talvey
Talquetamab is marketed as TALVEY, a bispecific GPRC5D-directed CD3 T-cell engager for heavily pretreated relapsed or refractory multiple myeloma. It is approved under accelerated approval based on response rate and durability of response, with continued approval contingent on confirmatory clinical benefit. U.S. initial approval was in 2023.
Johnson & Johnson raised its full-year forecast after stronger-than-expected quarterly results driven by cancer, immunology and neuroscience drugs. Sales were $24.56 billion and adjusted earnings were $2.46 per share, with Innovative Medicines sales rising 10.0% to $15.76 billion.
The multiple myeloma treatment landscape is rapidly expanding with over 75 companies developing 80+ pipeline therapies, while clinicians navigate evolving questions about transplant timing, quadruplet regimens, and minimal residual disease testing in newly diagnosed patients.
MajesTEC-9 trial demonstrates teclistamab's superiority over standard care in second-line multiple myeloma treatment, with significant progression-free survival and overall survival benefits supporting earlier use of the BCMA-targeting bispecific antibody.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
New CAR T-cell approaches targeting BCMA and CD19 simultaneously show encouraging early results, while researchers develop control strategies for CAR-T therapies including antibody-drug conjugates.
The FDA has approved a new monthly dosing schedule for Johnson & Johnson's Rybrevant Faspro combined with Lazcluze for first-line treatment of advanced EGFR-mutated non-small cell lung cancer, allowing patients to transition to monthly dosing as early as week five.
T-cell immunotherapies including CAR T-cell therapy and T-cell engagers are expanding cancer treatment options but present significant cardiovascular risks and operational complexities requiring coordinated multidisciplinary management.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07499323 |
Talquetamab in Patients With Refractory Generalized Myasthenia Gravis |
NOT_YET_RECRUITING | NA |
| NCT07107529 |
Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab. |
RECRUITING | PHASE2 |
| NCT07093554 |
Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma |
RECRUITING | PHASE1 |
| NCT07032714 |
Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma |
RECRUITING | PHASE1 |
| NCT06993675 |
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE) |
RECRUITING | PHASE2 |
| NCT06855121 |
The Norwegian Immunotherapy in Multiple Myeloma Study |
RECRUITING | |
| NCT06827860 |
Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse |
RECRUITING | PHASE2 |
| NCT06577025 |
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 |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06572605 |
External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease |
RECRUITING | PHASE1/PHASE2 |
| NCT06550895 |
A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma |
ACTIVE_NOT_RECRUITING | PHASE2 |
