The US FDA (Food and Drug Administration) has granted Seagen and Genmab accelerated approval for TIVDAK (tisotumab vedotin-tftv) to treat adult patients with recurring or metastatic cervical cancer who have previously received disease progression or chemotherapy. Approved under the FDA’s Accelerated Approval Program, TIVDAK the first and only approved antibody-drug conjugate (ADC) for this type of cervical cancer. The approval is based on the innovaTV 204 clinical trial in which 101 patients with recurrent or metastatic cervical cancer received TIVDAK. In 2021 it is predicted that over 14,480 new cases of invasive cervical cancer will be diagnosed in the U.S.
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