Cosibelimab: First Approval

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Arnold Lee is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable

Additional information about this Adis Drug Review can be found here.

Abstract

Cosibelimab (UNLOXCYT; cosibelimab-ipdl) is an anti-PD-L1 antibody developed by Checkpoint Therapeutics for the treatment of advanced cancers, including metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC). Cosibelimab is the first approved anti-PD-L1 therapy in the USA for the treatment of adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation. In contrast to other anti-PD-L1 antibodies, cosibelimab can induce antibody-dependent cell mediated cytotoxicity as it includes a functional Fc domain. This article summarizes the milestones in the development of cosibelimab leading to this first approval for this indication. 

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