teclistamab
{{Short description|Monoclonal antibody}}
{{Use American English|date=July 2022}}
{{Use dmy dates|date=July 2022}}
{{Infobox drug
| type = mab
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| mab_type = bite
| source = zu
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| DailyMedID = Teclistamab
| pregnancy_AU = C
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| routes_of_administration = Subcutaneous injection
| class = Antineoplastic
| ATCvet =
| ATC_prefix = L01
| ATC_suffix = FX24
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| biosimilars =
| legal_AU = S4
| legal_BR =
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = {{cite web | title=Details for: Tecvayli | website=Health Canada | date=20 October 2023 | url=https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102849 | access-date=3 March 2024 | archive-date=3 March 2024 | archive-url=https://web.archive.org/web/20240303055320/https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102849 | url-status=live }}{{cite web | title=Notice: Multiple additions to the Prescription Drug List (PDL) [2023-10-26] | website=Health Canada | date=26 October 2023 | url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2023-10-26.html | access-date=3 January 2024 | archive-date=3 January 2024 | archive-url=https://web.archive.org/web/20240103061027/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2023-10-26.html | url-status=live }}
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| legal_US = Rx-only
| legal_US_comment = {{cite web | title=Tecvayli- teclistamab injection | website=DailyMed | date=31 October 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e | access-date=18 November 2022 | archive-date=18 November 2022 | archive-url=https://web.archive.org/web/20221118234902/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e | url-status=live }}{{cite web | title=Drug Approval Package: Tecvayli | publisher=U.S. Food and Drug Administration (FDA) | date=23 November 2022 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761291Orig1s000TOC.cfm | access-date=4 December 2022 | archive-date=4 December 2022 | archive-url=https://web.archive.org/web/20221204074317/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761291Orig1s000TOC.cfm | url-status=dead }}
| legal_EU = Rx-only
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| CAS_number = 2119595-80-9
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| DrugBank = DB16655
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| UNII = 54534MX6Z9
| KEGG = D12177
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| synonyms = JNJ-64007957, teclistamab-cqyv
| IUPAC_name =
| C = 6383
| H = 9847
| N = 1695
| O = 2003
| S = 40
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Teclistamab, sold under the brand name Tecvayli, is a human bispecific monoclonal antibody used for the treatment of relapsed and refractory multiple myeloma. 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.
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.
Teclistamab is the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. Teclistamab was approved for medical use in the European Union in August 2022,{{cite press release | title=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 | website=Janssen Pharmaceutical Companies | date=24 August 2022 | url=https://www.jnj.com/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 | access-date=26 October 2022 | archive-date=26 October 2022 | archive-url=https://web.archive.org/web/20221026192404/https://www.jnj.com/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 | url-status=live }} and in the United States in October 2022.{{cite web | title=FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma | publisher=U.S. Food and Drug Administration (FDA) | date=25 October 2022 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma | access-date=28 October 2022 | archive-date=27 October 2022 | archive-url=https://web.archive.org/web/20221027170902/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma | url-status=dead }} {{PD-notice}}{{cite web | title=Tecvayli: FDA-Approved Drugs | publisher=U.S. Food and Drug Administration (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761291 | access-date=27 October 2022 | archive-date=27 October 2022 | archive-url=https://web.archive.org/web/20221027034700/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761291 | url-status=dead }}{{cite web | title=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 | website=Janssen Pharmaceutical Companies | date=25 October 2022 | url=https://www.jnj.com/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 | access-date=26 October 2022 | archive-date=10 March 2024 | archive-url=https://web.archive.org/web/20240310061504/https://www.jnj.com/media-center/press-releases/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 | url-status=live }}{{cite journal | vauthors = Kang C | title = Teclistamab: First Approval | journal = Drugs | volume = 82 | issue = 16 | pages = 1613–1619 | date = November 2022 | pmid = 36352205 | pmc = 9646474 | doi = 10.1007/s40265-022-01793-1 | url = }} The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.{{cite web | title=Advancing Health Through Innovation: New Drug Therapy Approvals 2022 | website=U.S. Food and Drug Administration (FDA) | date=10 January 2023 | url=https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022 | access-date=22 January 2023 | archive-date=21 January 2023 | archive-url=https://web.archive.org/web/20230121035714/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022 | url-status=dead }} {{PD-notice}}{{cite report | title=New Drug Therapy Approvals 2022 | website=U.S. Food and Drug Administration (FDA) | date=January 2024 | url=https://www.fda.gov/media/164429/download | format=PDF | access-date=14 January 2024 | archive-url=https://web.archive.org/web/20240114065648/https://www.fda.gov/media/164429/download | archive-date=14 January 2024 | url-status=dead }} {{PD-notice}}
Medical uses
Teclistamab is indicated for the treatment of adults with relapsed and refractory multiple myeloma.{{cite journal | vauthors = Pan D, Richter J | title = Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody | journal = Cancer Management and Research | volume = 15 | issue = | pages = 741–751 | date = 2023 | pmid = 37497430 | pmc = 10368105 | doi = 10.2147/CMAR.S372237 | url = | doi-access = free }}{{cite journal | vauthors = Martino EA, Bruzzese A, Labanca C, Mendicino F, Lucia E, Olivito V, Neri A, Morabito F, Vigna E, Gentile M | title = Teclistamab-cqyv in multiple myeloma | journal = European Journal of Haematology | volume = 112| issue = 3| pages = 320–327| date = October 2023 | pmid = 37848191 | doi = 10.1111/ejh.14121 | url = | doi-access = free }}
Contraindications
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). Among people who received teclistamab at the recommended dose, CRS occurred in 72%, neurologic toxicity in 57%, and ICANS in 6%. Grade 3 CRS occurred in 0.6% of people and Grade 3 or 4 neurologic toxicity occurred in 2.4%.
Adverse effects
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. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.
History
Teclistamab-cqyv was evaluated in MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi-cohort, open-label, multi-center study. 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.
The application for teclistamab was granted orphan drug, priority review, and breakthrough therapy designations.
Society and culture
= Legal status =
In 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.{{cite press release | title=Janssen Receives Positive CHMP Opinion for Novel Bispecific Antibody Tecvayli (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (RRMM) | website=Janssen | date=22 July 2022 | url=https://www.jnj.com/janssen-receives-positive-chmp-opinion-for-novel-bispecific-antibody-tecvayli-teclistamab-for-the-treatment-of-patients-with-relapsed-and-refractory-multiple-myeloma-rrmm | access-date=30 July 2022 | archive-date=30 July 2022 | archive-url=https://web.archive.org/web/20220730055647/https://www.jnj.com/janssen-receives-positive-chmp-opinion-for-novel-bispecific-antibody-tecvayli-teclistamab-for-the-treatment-of-patients-with-relapsed-and-refractory-multiple-myeloma-rrmm | url-status=live }} Tecvayli was reviewed under EMA's accelerated assessment program. The applicant for this medicinal product is Janssen-Cilag International N.V. Teclistamab was authorized for medical use in the European Union in August 2022.{{cite web | title=Tecvayli Product information | website=Union Register of medicinal products | date=12 December 2022 | url=https://ec.europa.eu/health/documents/community-register/html/h1675.htm | access-date=3 March 2023 | archive-date=3 March 2023 | archive-url=https://web.archive.org/web/20230303200203/https://ec.europa.eu/health/documents/community-register/html/h1675.htm | url-status=live }}
= Names =
Teclistamab is the international nonproprietary name and owned by Genmab A/S (INN).{{cite journal | vauthors = ((World Health Organization)) | year = 2019 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82 | journal = WHO Drug Information | volume = 33 | issue = 3 | page = | hdl = 10665/330879 | hdl-access = free | author-link = World Health Organization }}
References
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Category:Monoclonal antibodies for tumors