| Monoclonal antibody | |
|---|---|
| Type | Bi-specific T-cell engager |
| Source | Humanized |
| Target | BCMA,CD3 |
| Clinical data | |
| Other names | JNJ-64007957, teclistamab-cqyv |
| License data | |
| Pregnancy category | |
| Routes of administration | Subcutaneous injection |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6383H9847N1695O2003S40 |
| Molar mass | 143662.25 g·mol−1 |
Teclistamab, sold under the brand nameTecvayli, is a humanbispecific monoclonal antibody used for the treatment of relapsed and refractorymultiple myeloma.[7] It is a bispecific antibody that targets theCD3 receptor expressed on the surface ofT-cells andB-cell maturation antigen (BCMA), which is expressed on the surface ofmalignant multiple myeloma B-lineage cells.[7][8]
The most common side effects includehypogammaglobulinemia (low immunoglobulin or antibody levels in the blood, which increases the risk of infection), cytokine release syndrome,neutropenia (low levels ofneutrophils, a type of white blood cell that fights infection),anemia (low levels of red blood cells or hemoglobin), pain in the muscles and bones, tiredness,thrombocytopenia (low levels of blood platelets, components that help the blood to clot),injection site reactions, upper respiratory tract (nose and throat) infection,lymphopenia (low levels oflymphocytes, a type of white blood cell),diarrhea,pneumonia (infection of the lungs), nausea (feeling sick), fever, headache, cough, constipation and pain.[7]
Teclistamab is the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.[9] Teclistamab was approved for medical use in the European Union in August 2022,[7][10] and in the United States in October 2022.[9][11][12][13] The USFood and Drug Administration (FDA) considers it to be afirst-in-class medication.[14][15]
Teclistamab isindicated for the treatment of adults with relapsed and refractory multiple myeloma.[5][7][16][17]
In the US, the prescribing information for teclistamab has aboxed warning for life threatening or fatalcytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associatedneurotoxicity (ICANS).[9] Among people who received teclistamab at the recommended dose, CRS occurred in 72%, neurologic toxicity in 57%, and ICANS in 6%.[9] Grade 3 CRS occurred in 0.6% of people and Grade 3 or 4 neurologic toxicity occurred in 2.4%.[9]
The most common adverse reactions (≥20%) occurring in the 165 patients in the safety population, were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.[9] The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.[9]
Teclistamab-cqyv was evaluated in MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi-cohort, open-label, multi-center study.[9] The efficacy population consisted of 110 participants who had previously received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and had not received prior BCMA-targeted therapy.[9]
The application for teclistamab was grantedorphan drug,priority review, andbreakthrough therapy designations.[9]
In July 2022, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Tecvayli, intended for treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies.[7][8] Tecvayli was reviewed under EMA's accelerated assessment program.[7] The applicant for this medicinal product is Janssen-Cilag International N.V.[7] Teclistamab was authorized for medical use in the European Union in August 2022.[7][18]
Teclistamab is theinternational nonproprietary name and owned by Genmab A/S (INN).[19]
This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain.
