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== 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" /><ref>{{Cite web |title=FDA approves Unloxcyt for advanced cutaneous squamous cell carcinoma |url=https://www.healio.com/news/hematology-oncology/20241216/fda-approves-unloxcyt-for-advanced-cutaneous-squamous-cell-carcinoma |access-date=2024-12-31 |website=www.healio.com |language=en}}</ref>


== 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" /> Nearly half of those who received the agent in the study responded to the therapy.<ref>{{Cite web |title=FDA approves Unloxcyt for advanced cutaneous squamous cell carcinoma |url=https://www.healio.com/news/hematology-oncology/20241216/fda-approves-unloxcyt-for-advanced-cutaneous-squamous-cell-carcinoma |access-date=2024-12-31 |website=www.healio.com |language=en}}</ref>


== Society and culture == == Society and culture ==

Revision as of 07:18, 31 December 2024

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

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 by the FDA 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. Nearly half of those who received the agent in the study responded to the therapy.

Society and culture

Legal status

Cosibelimab was approved by the FDA 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

  1. ^ https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761297s000lbl.pdf
  2. ^ "FDA approves cosibelimab-ipdl". U.S. Food and Drug Administration (FDA). 13 December 2024. Retrieved 17 December 2024. Public Domain 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. Retrieved 20 December 2024.
  4. "FDA approves Unloxcyt for advanced cutaneous squamous cell carcinoma". www.healio.com. Retrieved 31 December 2024.
  5. "FDA approves Unloxcyt for advanced cutaneous squamous cell carcinoma". www.healio.com. Retrieved 31 December 2024.
  6. "Checkpoint Therapeutics Announces FDA Approval of Unloxcyt (cosibelimab-ipdl)". Checkpoint Therapeutics (Press release). 13 December 2024. Retrieved 17 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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