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Cosibelimab

From Wikipedia, the free encyclopedia
Medication

Pharmaceutical compound
Cosibelimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetPD-L1
Clinical data
Trade namesUnloxcyt
Other namesCK-301, TG-1501, cosibelimab-ipdl
License data
Drug classAntineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6388H9912N1716O2032S44
Molar mass144674.18 g·mol−1

Cosibelimab, sold under the brand nameUnloxcyt, is a monoclonal antibody used for the treatment ofcutaneous squamous-cell carcinoma.[1] It is a human immunoglobulin G1 (IgG1) programmed death ligand-1 (PD-L1) blocking antibody.[1][2]

The most common adverse reactions include fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, and urinary tract infection.[3]

Cosibelimab was approved for medical use in the United States in December 2024.[1][3][4][5]

Medical uses

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Cosibelimab isindicated for the treatment of adults with metastaticcutaneous squamous-cell carcinoma or locally advanced cutaneous squamous-cell carcinoma who are not candidates for curative surgery or curative radiation.[1][3]

History

[edit]

Efficacy was evaluated in study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label trial in 109 participants with metastatic cutaneous squamous-cell carcinoma or locally advanced cutaneous squamous-cell carcinoma who were not candidates for curative surgery or curative radiation.[3] Participants were excluded if they had any of the following: active or suspected autoimmune disease, allogeneic transplant within six months prior to treatment, prior treatment with anti-PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy, uncontrolled or significant cardiovascular disease, ECOG PS • 2, or infection with HIV, hepatitis B, or hepatitis C.[3]

Society and culture

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Legal status

[edit]

Cosibelimab was approved for medical use in the United States in December 2024.[3][6]

Names

[edit]

Cosibelimab is theinternational nonproprietary name.[7]

Cosibelimab is sold under the brand name Unloxcyt.[1]

References

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  1. ^abcdefhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761297s000lbl.pdf
  2. ^https://checkpointtx.com/pipeline/cosibelimab/
  3. ^abcdef"FDA approves cosibelimab-ipdl".U.S.Food and Drug Administration (FDA). 13 December 2024. Retrieved17 December 2024.Public Domain This article incorporates text from this source, which is in thepublic domain.
  4. ^"Novel Drug Approvals for 2024".U.S.Food and Drug Administration (FDA). 1 October 2024. Retrieved20 December 2024.
  5. ^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.
  6. ^"Checkpoint Therapeutics Announces FDA Approval of Unloxcyt (cosibelimab-ipdl)".Checkpoint Therapeutics (Press release). 13 December 2024. Retrieved17 December 2024.
  7. ^World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83".WHO Drug Information.34 (1).hdl:10665/339768.

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