Tisotumab Vedotin: 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. A. Markham is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article 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

Tisotumab vedotin (Tivdak™) is an antibody-drug conjugate comprising a fully human monoclonal antibody specific for tissue factor (TF-011) conjugated to monomethyl auristatin E (MMAE) that has been engineered to target tissue factor expressing tumours. Based on the results of a phase II trial, tisotumab vedotin has been granted accelerated approval in the USA for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This article summarizes the milestones in the development of tisotumab vedotin leading to this first approval.

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