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| The most common adverse reactions include fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, and urinary tract infection.<ref name="FDA 20241213" /> | The most common adverse reactions include fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, and urinary tract infection.<ref name="FDA 20241213" /> | ||
| Cosibelimab was approved |
Cosibelimab was approved for medical use in the United States in December 2024.<ref name="Unloxcyt FDA label" /><ref name="FDA 20241213">{{cite web | title=FDA approves cosibelimab-ipdl | website=U.S. ] (FDA) | date=13 December 2024 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cosibelimab-ipdl-metastatic-or-locally-advanced-cutaneous-squamous-cell-carcinoma | access-date=17 December 2024}} {{PD-notice}}</ref><ref name="Novel Drug Approvals for 2024">{{cite web | title=Novel Drug Approvals for 2024 | website=U.S. ] (FDA) | date=1 October 2024 | url=https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 | access-date=20 December 2024}}</ref> | ||
| == Medical uses == | == Medical uses == | ||
| Cosibelimab is ] for the treatment of adults with metastatic ] or locally advanced cutaneous squamous-cell carcinoma who are not candidates for curative surgery or curative radiation.<ref name="Unloxcyt FDA label" /><ref name="FDA 20241213" / |
Cosibelimab is ] for the treatment of adults with metastatic ] or locally advanced cutaneous squamous-cell carcinoma who are not candidates for curative surgery or curative radiation.<ref name="Unloxcyt FDA label" /><ref name="FDA 20241213" /> | ||
| == History == | == 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.<ref name="FDA 20241213" /> 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.<ref name="FDA 20241213" / |
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.<ref name="FDA 20241213" /> 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.<ref name="FDA 20241213" /> | ||
| == Society and culture == | == Society and culture == | ||
| === Legal status === | === Legal status === | ||
| Cosibelimab was approved |
Cosibelimab was approved for medical use in the United States in December 2024.<ref name="FDA 20241213" /><ref>{{cite press release | title=Checkpoint Therapeutics Announces FDA Approval of Unloxcyt (cosibelimab-ipdl) | website=Checkpoint Therapeutics | date=13 December 2024 | url=https://ir.checkpointtx.com/news-events/press-releases/detail/127/checkpoint-therapeutics-announces-fda-approval-of | access-date=17 December 2024}}</ref> | ||
| === Names === | === Names === | ||
Latest revision as of 07:42, 31 December 2024
MedicationPharmaceutical compound
| 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 |
Cosibelimab, sold under the brand name Unloxcyt, is a monoclonal antibody used for the treatment of cutaneous squamous-cell carcinoma. It is a programmed death ligand-1 (PD-L1) blocking antibody.
The most common adverse reactions include fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, and urinary tract infection.
Cosibelimab was approved for medical use in the United States in December 2024.
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.
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. 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.
Society and culture
Legal status
Cosibelimab was approved for medical use in the United States in December 2024.
Names
Cosibelimab is the international nonproprietary name.
Cosibelimab is sold under the brand name Unloxcyt.
References
- ^ https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761297s000lbl.pdf
- ^ "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
- "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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