Seagen's Tivdak Bags US FDA Nod To Treat Metastatic Cervical Cancer

The US Food and Drug Administration has granted full clearance to Seagen Inc.'s Tivdak (tisotumab vedotin), which targets tissue factor (TF), for the treatment of patients with recurrent or metastatic cervical cancer who have progressed during or after chemotherapy. This is a substantial development in the treatment landscape for cervical cancer, demonstrating the potential of antibody-drug conjugates (ADCs) in oncology.

Tivdak is a tissue factor-targeting antibody-drug conjugate medication that combines the tissue factor-targeting monoclonal antibody tisotumab from Genmab with the antibody-drug conjugates technology from Seagen. This combination allows the drug to directly target tissue factor antigens on cancer cells and deliver the cytotoxic payload of MMAE.

Tissue factor is overexpressed in the majority of patients with cervical cancer and in many other solid tumors, and it is known to be implicated in tumor signaling and angiogenesis pathways. Its suitability for targeted cancer therapy is further enhanced by its low impact on normal coagulation processes and its ability to internalize quickly when bound by antibodies.

Tivdak is used to treat adult patients with recurrent or metastatic cervical cancer that progresses during or after chemotherapy.  This indication has been approved for accelerated approval based on tumor response rate and response durability. Continued clearance for this indication may be conditional on the verification and description of clinical benefit in confirmatory clinical trials.