Tivdak

Tivdak is the brand name for tisotumab vedotin, an antibody-drug conjugate developed by Seagen. It targets tissue factor (TF), a protein overexpressed in many solid tumors, including cervical cancer. The drug combines a human monoclonal antibody against TF with MMAE, a cytotoxic agent that disrupts microtubules, connected by a protease-cleavable linker. After binding TF on tumor cells, Tivdak is internalized and MMAE is released inside the cell, inhibiting tubulin polymerization and triggering cell death. TF is also present in tumor vasculature, potentially enabling broader anti-tumor effects.

Indications and usage: In the United States, Tivdak was approved for adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval was based on results from the pivotal INNOVA-TV 206 trial, which demonstrated objective responses in a subset of patients and responses of meaningful duration. It is used as a single-agent therapy.

Administration and dosing: Tivdak is given as an intravenous infusion every three weeks. Treatment continues until disease progression or unacceptable toxicity. Premedication and management of side effects follow the labeling, and patients require regular ophthalmologic assessments due to the risk of ocular toxicity.

Safety: Common adverse events include fatigue, nausea, decreased appetite, and ocular events such as keratopathy or conjunctival toxicity; hemorrhage, epistaxis, anemia, and other cytopenias can occur. A boxed warning highlights ocular toxicity and the need for eye examinations before and during treatment.

Research: Investigational in other TF-expressing tumors, with ongoing trials evaluating efficacy in additional cancers and in combination regimens.