Teclistamab
| Monoclonal antibody | |
|---|---|
| Type | Bi-specific T-cell engager |
| Source | Humanized |
| Target | BCMA, CD3 |
| Clinical data | |
| Other names | JNJ-64007957, teclistamab-cqyv |
| License data |
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| Pregnancy category |
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| 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 name Tecvayli, is a human bispecific monoclonal antibody used for the treatment of relapsed and refractory multiple myeloma.[8] It is a bispecific antibody that targets the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells.[8][9]
The most common side effects include hypogammaglobulinemia (low immunoglobulin or antibody levels in the blood, which increases the risk of infection), cytokine release syndrome, neutropenia (low levels of neutrophils, 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 of lymphocytes, a type of white blood cell), diarrhea, pneumonia (infection of the lungs), nausea (feeling sick), fever, headache, cough, constipation and pain.[8]
Teclistamab is the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.[10] Teclistamab was approved for medical use in the European Union in August 2022,[8][11] and in the United States in October 2022.[10][12][13][14] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[15][16]
Medical uses
[edit]Teclistamab is indicated for the treatment of adults with relapsed and refractory multiple myeloma.[6][8][17][18]
Contraindications
[edit]In the US, the prescribing information for teclistamab has a boxed warning for life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS).[10] Among people who received teclistamab at the recommended dose, CRS occurred in 72%, neurologic toxicity in 57%, and ICANS in 6%.[10] Grade 3 CRS occurred in 0.6% of people and Grade 3 or 4 neurologic toxicity occurred in 2.4%.[10]
Adverse effects
[edit]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.[10] The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.[10]
History
[edit]Teclistamab-cqyv was evaluated in MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi-cohort, open-label, multi-center study.[10] 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.[10]
The application for teclistamab was granted orphan drug, priority review, and breakthrough therapy designations.[10]
Society and culture
[edit]Legal status
[edit]On 21 July 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European 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.[8][9] Tecvayli was reviewed under EMA's accelerated assessment program.[8] The applicant for this medicinal product is Janssen-Cilag International N.V.[8] Teclistamab was approved for medical use in the European Union in August 2022.[8][19]
Names
[edit]Teclistamab is the international nonproprietary name and owned by Genmab A/S (INN).[20]
References
[edit]- ^ "Tecvayli". Therapeutic Goods Administration (TGA). 28 June 2023. Archived from the original on 19 November 2023. Retrieved 10 September 2023.
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
- ^ "Tecvayli (Janssen-Cilag Pty Ltd)". Therapeutic Goods Administration (TGA). 28 July 2023. Archived from the original on 19 November 2023. Retrieved 10 September 2023.
- ^ "Details for: Tecvayli". Health Canada. 20 October 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
- ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-10-26]". Health Canada. 26 October 2023. Archived from the original on 3 January 2024. Retrieved 3 January 2024.
- ^ a b "Tecvayli- teclistamab injection". DailyMed. 31 October 2022. Archived from the original on 18 November 2022. Retrieved 18 November 2022.
- ^ "Drug Approval Package: Tecvayli". U.S. Food and Drug Administration (FDA). 23 November 2022. Archived from the original on 4 December 2022. Retrieved 4 December 2022.
- ^ a b c d e f g h i j "Tecvayli EPAR". European Medicines Agency. 18 July 2022. Archived from the original on 10 December 2022. Retrieved 14 October 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b "Janssen Receives Positive CHMP Opinion for Novel Bispecific Antibody Tecvayli (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (RRMM)". Janssen (Press release). 22 July 2022. Archived from the original on 30 July 2022. Retrieved 30 July 2022.
- ^ a b c d e f g h i j "FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma". U.S. Food and Drug Administration (FDA). 25 October 2022. Archived from the original on 27 October 2022. Retrieved 28 October 2022.
This article incorporates text from this source, which is in the public domain.
- ^ "Janssen Marks First Approval Worldwide for Tecvayli (teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma". Janssen Pharmaceutical Companies (Press release). 24 August 2022. Archived from the original on 26 October 2022. Retrieved 26 October 2022.
- ^ "Tecvayli: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 27 October 2022. Retrieved 27 October 2022.
- ^ "U.S. FDA Approves Tecvayli (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma". Janssen Pharmaceutical Companies. 25 October 2022. Archived from the original on 10 March 2024. Retrieved 26 October 2022.
- ^ Kang C (November 2022). "Teclistamab: First Approval". Drugs. 82 (16): 1613–1619. doi:10.1007/s40265-022-01793-1. PMC 9646474. PMID 36352205.
- ^ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Archived from the original on 21 January 2023. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.
- ^ New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024. This article incorporates text from this source, which is in the public domain.
- ^ Pan D, Richter J (2023). "Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody". Cancer Management and Research. 15: 741–751. doi:10.2147/CMAR.S372237. PMC 10368105. PMID 37497430.
- ^ Martino EA, Bruzzese A, Labanca C, Mendicino F, Lucia E, Olivito V, Neri A, Morabito F, Vigna E, Gentile M (October 2023). "Teclistamab-cqyv in multiple myeloma". European Journal of Haematology. 112 (3): 320–327. doi:10.1111/ejh.14121. PMID 37848191.
- ^ "Tecvayli Product information". Union Register of medicinal products. 12 December 2022. Archived from the original on 3 March 2023. Retrieved 3 March 2023.
- ^ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl:10665/330879.
