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][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. ^ a b c d e f https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761297s000lbl.pdf
  2. ^ a b c d e f "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. ^ 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.


Allikas: https://en.wikipedia.org/wiki/Cosibelimab
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