Overview
Talquetamab is a IgG4-PAA bispecific G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CD3 T-cell engager. It consists of two arms - anti-GPRC5D and anti-CD3 arms - linked by two interchain disulfide bonds, each arm comprising a heavy and light chain. Talquetamab binds to GPRC5D, a cell surface receptor expressed predominantly on multiple myeloma cells, and CD3 on T cells. It works to recruit CD3-expressing T cells to GPRC5D-expressing multiple myeloma cells to induce T-cell–mediated cytotoxicity. The Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended conditional marketing authorization for talquetamab for the treatment of relapsed or refractory multiple myeloma on July 21, 2023. On August 9, 2023, talquetamab was granted FDA accelerated approval.
Indication
In the US, talquetamab is indicated for the treatment of adult patients 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. In Europe, talquetamab is indicated in patients who received at least three prior therapies and have demonstrated disease progression on the last therapy. These indications are contingent, as talquetamab is only approved under accelerated approval in the US and conditional marketing authorization in Europe. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Associated Conditions
- Refractory Multiple Myeloma
- Relapsed Multiple Myeloma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/24 | Phase 1 | Not yet recruiting | |||
2025/05/29 | Phase 2 | Not yet recruiting | Noffar Bar | ||
2025/03/03 | N/A | Recruiting | St. Olavs Hospital | ||
2025/02/14 | Phase 2 | Recruiting | Larysa Sanchez | ||
2024/08/29 | Phase 2 | Recruiting | |||
2024/08/27 | Phase 1 | Not yet recruiting | City of Hope Medical Center | ||
2024/08/13 | Phase 2 | Recruiting | |||
2024/07/17 | Phase 2 | Recruiting | North Estonia Medical Centre | ||
2024/07/15 | Phase 2 | Recruiting | |||
2024/06/17 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Janssen Biotech, Inc. | 57894-469 | SUBCUTANEOUS | 3 mg in 1.5 mL | 8/18/2023 | |
| Janssen Biotech, Inc. | 57894-470 | SUBCUTANEOUS | 40 mg in 1 mL | 8/18/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/21/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TALVEY SOLUTION FOR INJECTION 3MG/1.5ML | SIN17141P | INJECTION, SOLUTION | 3mg/1.5mL | 11/15/2024 | |
| TALVEY SOLUTION FOR INJECTION 40MG/ML | SIN17142P | INJECTION, SOLUTION | 40mg/mL | 11/15/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TALVEY SOLUTION FOR INJECTION 3MG/1.5ML | N/A | N/A | N/A | 12/16/2024 | |
| TALVEY SOLUTION FOR INJECTION 40MG/1ML | N/A | N/A | N/A | 12/16/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TALVEY talquetamab 40 mg/mL solution for injection vial | 409912 | Medicine | A | 9/26/2024 | |
| TALVEY talquetamab 2 mg/mL solution for injection vial | 409913 | Medicine | A | 9/26/2024 |
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