Movatterモバイル変換


[0]ホーム

URL:


Jump to content
WikipediaThe Free Encyclopedia
Search

Tarlatamab

From Wikipedia, the free encyclopedia
Monoclonal antibody

Pharmaceutical compound
Tarlatamab
Monoclonal antibody
TypeBi-specific T-cell engager
SourceHuman
TargetDLL3 andCD3
Clinical data
Trade namesImdelltra
Other namesAMG757; AMG-757, tarlatamab-dlle
AHFS/Drugs.comMultum Consumer Information
License data
Routes of
administration
Intravenous
Drug classAntineoplastic
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC4664H7139N1259O1454S34
Molar mass105202.82 g·mol−1

Tarlatamab, sold under the brand nameImdelltra, is ananti-cancer medication used for the treatment of extensive-stagesmall cell lung cancer.[4] It is abispecific T-cell engager that bindsdelta-like ligand 3 and CD3.[4]

The most common adverse reactions include cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea.[5]

Tarlatamab was approved for medical use in the United States in May 2024.[5][6] The USFood and Drug Administration (FDA) considers it to be afirst-in-class medication.[7]

Medical uses

[edit]

Tarlatamab isindicated for the treatment of adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.[4][5]

Adverse effects

[edit]

The prescribing information for tarlatamab includes aboxed warning for serious or life-threatening cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).[4]

The most common adverse reactions include cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea.[5] The most common grade 3 or 4 laboratory abnormalities include decreased lymphocytes, decreased sodium, increased uric acid, decreased total neutrophils, decreased hemoglobin, increased activated partial thromboplastin time, and decreased potassium.[5]

History

[edit]

Efficacy was evaluated in 99 participants with relapsed/refractory extensive stage small cell lung cancer with disease progression following platinum-based chemotherapy enrolled in DeLLphi-301 [NCT05060016], an open-label, multicenter, multi-cohort study.[5] Participants with symptomatic brain metastases, interstitial lung disease or non-infectious pneumonitis, and active immunodeficiency were excluded.[5] Participants received tarlatamab until disease progression or unacceptable toxicity.[5]

The FDA granted the application for tarlatamabpriority review,breakthrough therapy, andorphan drug designations.[5]

Society and culture

[edit]

Legal status

[edit]

Tarlatamab was approved for medical use in the United States in May 2024.[5][6][8][9]

Names

[edit]

Tarlatamab is theinternational nonproprietary name[10] and theUnited States Adopted Name.[11]

References

[edit]
  1. ^"Notice: Multiple additions to the Prescription Drug List (PDL) [2024-12-20]".Health Canada. 20 December 2024. Retrieved21 December 2024.
  2. ^"Imdelltra product information".Health Canada. 11 October 2024. Retrieved27 December 2024.
  3. ^"Regulatory Decision Summary for Imdelltra".Drug and Health Products Portal. 11 September 2024. Retrieved27 December 2024.
  4. ^abcde"Imdelltra (AMG757)- tarlatamab-dlle kit".DailyMed. 16 May 2024. Retrieved31 May 2024.
  5. ^abcdefghij"FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer".U.S.Food and Drug Administration (FDA). 16 May 2024. Retrieved17 May 2024.Public Domain This article incorporates text from this source, which is in thepublic domain.
  6. ^ab"Novel Drug Approvals for 2024".U.S.Food and Drug Administration (FDA). 1 October 2024. Retrieved29 November 2024.
  7. ^New Drug Therapy Approvals 2024(PDF).U.S.Food and Drug Administration (FDA) (Report). January 2025.Archived from the original on 21 January 2025. Retrieved21 January 2025.
  8. ^"Cancer Accelerated Approvals".U.S.Food and Drug Administration (FDA). 1 October 2024. Retrieved6 December 2024.
  9. ^"FDA approves Imdelltra (tarlatamab-dlle), the first and only T-cell engager therapy for the treatment of extensive-stage small cell lung cancer" (Press release). Amgen. 16 May 2024. Retrieved18 May 2024 – via PR Newswire.
  10. ^World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85".WHO Drug Information.35 (1).hdl:10665/340684.
  11. ^"Tarlatamab".AMA Finder. Retrieved18 May 2024.

Further reading

[edit]

External links

[edit]
CImonoclonal antibodies ("-mab")
Receptor tyrosine kinase
Others for solid tumors
Leukemia/lymphoma
Other
Tyrosine kinase inhibitors ("-nib")
Receptor tyrosine kinase
Non-receptor
Other
Tumor
Human
Mouse
Chimeric
Humanized
Rat/mouse hybrid
Chimeric + humanized
Portal:
Retrieved from "https://en.wikipedia.org/w/index.php?title=Tarlatamab&oldid=1270779778"
Categories:
Hidden categories:

[8]ページ先頭

©2009-2025 Movatter.jp