Cosibelimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | PD-L1 |
| Clinical data | |
| Trade names | Unloxcyt |
| Other names | CK-301, TG-1501, cosibelimab-ipdl |
| License data |
|
| Drug class | Antineoplastic |
| ATC code |
|
| 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 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]
Medical uses
[edit]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
[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
[edit]Legal status
[edit]Cosibelimab was approved for medical use in the United States in December 2024.[2][4]
Names
[edit]Cosibelimab is the international nonproprietary name.[5]
Cosibelimab is sold under the brand name Unloxcyt.[1]
References
[edit]- ^ a b c d e f https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761297s000lbl.pdf
- ^ a b c d e f "FDA approves cosibelimab-ipdl". U.S. Food and Drug Administration (FDA). 13 December 2024. Retrieved 17 December 2024.
This article incorporates text from this source, which is in the public domain.
- ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 20 December 2024.
- ^ "Checkpoint Therapeutics Announces FDA Approval of Unloxcyt (cosibelimab-ipdl)". Checkpoint Therapeutics (Press release). 13 December 2024. Retrieved 17 December 2024.
- ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.
External links
[edit]- "Cosibelimab-ipdl". NCI Drug Dictionary.
- "Cosibelimab (Code C151947)". NCI Thesaurus.
- Clinical trial number NCT03212404 for "Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers" at ClinicalTrials.gov
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