Cosibelimab

Last updated

Cosibelimab
Monoclonal antibody
Type Whole antibody
Source Human
Target PD-L1
Clinical data
Trade names Unloxcyt
Other namesCK-301, TG-1501, cosibelimab-ipdl
License data
Drug class Antineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
Formula C6388H9912N1716O2032S44
Molar mass 144674.18 g·mol−1

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

Contents

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

Cosibelimab is indicated for the treatment of adults with metastatic cutaneous squamous-cell carcinoma or locally advanced cutaneous squamous-cell carcinoma who are not candidates for curative surgery or curative radiation. [1] [2]

History

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

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

Names

Cosibelimab is the international nonproprietary name. [6]

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

References

  1. 1 2 3 4 5 6 https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761297s000lbl.pdf [ bare URL PDF ]
  2. 1 2 3 4 5 6 "FDA approves cosibelimab-ipdl". U.S. Food and Drug Administration (FDA). 13 December 2024. Archived from the original on 13 December 2024. Retrieved 17 December 2024.PD-icon.svg This article incorporates text from this source, which is in the public 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. Retrieved 20 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. Retrieved 21 January 2025.
  5. ↑ "Checkpoint Therapeutics Announces FDA Approval of Unloxcyt (cosibelimab-ipdl)". Checkpoint Therapeutics (Press release). 13 December 2024. Retrieved 17 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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