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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]

The most common adverse reactions include fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, and urinary tract infection.[2]

Cosibelimab was approved for medical use in the United States in December 2024.[1][2][3][4]

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][2]

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.[2] 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.[2]

Society and culture

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Legal status

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Cosibelimab was approved for medical use in the United States in December 2024.[2][5]

Names

[edit]

Cosibelimab is theinternational nonproprietary name.[6]

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[bare URL PDF]
  2. ^abcdef"FDA approves cosibelimab-ipdl".U.S.Food and Drug Administration (FDA). 13 December 2024.Archived from the original on 13 December 2024. Retrieved17 December 2024.Public Domain This article incorporates text from this source, which is in thepublic domain.
  3. ^"Novel Drug Approvals for 2024".U.S.Food and Drug Administration (FDA). 1 October 2024.Archived from the original on 19 April 2024. Retrieved20 December 2024.
  4. ^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.
  5. ^"Checkpoint Therapeutics Announces FDA Approval of Unloxcyt (cosibelimab-ipdl)".Checkpoint Therapeutics (Press release). 13 December 2024. Retrieved17 December 2024.
  6. ^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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