Seagen and Genmab Announce FDA Accelerated Approval for Tivdak (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer

Seagen and Genmab Announce FDA Accelerated Approval for Tivdak (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer

Seagen and Genmab announced the FDA has granted accelerated approval to Tivdak (tisotumab-vedotin-tftv), its antibody-drug conjugate (ADC) as monotherapy treatment for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tivdak was granted accelerated approval based on tumor response and the durability of the response observed in the Phase II innovaTV 204 clinical trial. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

The innovaTV 204 clinical trial was an open-label, multicenter, single-arm phase 2 trial in 101 patients with recurrent or metastatic cervical cancer. The patients had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Results from the trial showed a 24 percent confirmed objective response rate (ORR), as assessed by an independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The median duration of response (DOR) was 8.3 months. The study was conducted by Genmab in collaboration wit...

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