Overview
Teclistamab is an IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA) expressed on malignant multiple myeloma cells. Teclistamab consists of an anti-BCMA arm and an anti-CD3 arm connected via two interchain disulfide bonds, allowing the drug to recruit CD3-expressing T cells to BCMA-expressing cells to promote T cell–mediated cytotoxicity. On August 24, 2022, the European Commission (EC) granted conditional marketing authorization of teclistamab as first-in-class bispecific antibody for the treatment of multiple myeloma, marking its first global approval. Teclistamab was later granted accelerated approval by the FDA on October 25, 2022.
Background
Teclistamab is an IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA) expressed on malignant multiple myeloma cells. Teclistamab consists of an anti-BCMA arm and an anti-CD3 arm connected via two interchain disulfide bonds, allowing the drug to recruit CD3-expressing T cells to BCMA-expressing cells to promote T cell–mediated cytotoxicity. On August 24, 2022, the European Commission (EC) granted conditional marketing authorization of teclistamab as first-in-class bispecific antibody for the treatment of multiple myeloma, marking its first global approval. Teclistamab was later granted accelerated approval by the FDA on October 25, 2022.
Indication
Teclistamab is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Teclistamab is approved by the EC and FDA under conditional marketing authorization and accelerated approval, respectively. New evidence for this drug will be continuously monitored and reviewed, which will affect continued approval for the drug's indication.
Associated Conditions
- Refractory Multiple Myeloma
- Relapsed Multiple Myeloma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/22 | Phase 4 | Recruiting | |||
2025/05/29 | Phase 2 | Not yet recruiting | Noffar Bar | ||
2025/04/29 | Phase 2 | Not yet recruiting | |||
2025/04/20 | Phase 2 | Recruiting | |||
2025/03/25 | Phase 2 | Not yet recruiting | |||
2025/03/03 | N/A | Recruiting | St. Olavs Hospital | ||
2025/01/03 | Phase 2 | Recruiting | Hospital Universitario Dr. Jose E. Gonzalez | ||
2024/11/21 | Not Applicable | Recruiting | |||
2024/10/21 | Phase 2 | Not yet recruiting | European Myeloma Network B.V. | ||
2024/09/19 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Janssen Biotech, Inc. | 57894-450 | SUBCUTANEOUS | 90 mg in 1 mL | 2/27/2024 | |
| Janssen Biotech, Inc. | 57894-449 | SUBCUTANEOUS | 10 mg in 1 mL | 2/27/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/23/2022 | ||
Authorised | 8/23/2022 | ||
Authorised | 8/23/2022 | ||
Authorised | 8/23/2022 | ||
Authorised | 8/23/2022 | ||
Authorised | 8/23/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TECVAYLI SOLUTION FOR INJECTION 10MG/ML | SIN16948P | INJECTION, SOLUTION | 10mg/mL | 2/16/2024 | |
| TECVAYLI SOLUTION FOR INJECTION 90MG/ML | SIN16949P | INJECTION, SOLUTION | 90mg/mL | 2/16/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Teclistamab Injection | 国药准字SJ20240025 | 生物制品 | 注射剂 | 6/18/2024 | |
| Teclistamab Injection | 国药准字SJ20240026 | 生物制品 | 注射剂 | 6/18/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TECVAYLI teclistamab 90mg/mL solution for injection vial | 387622 | Medicine | A | 6/14/2023 | |
| TECVAYLI teclistamab 10mg/mL solution for injection vial | 387621 | Medicine | A | 6/14/2023 |