Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv) Receive the US FDA’s Accelerated Approval for the Treatment of Recurrent or Metastatic Cervical Cancer

September 22, 2021 Auto Bot cervical cancer, FDA, Genmab, regulatory, Seagen 0

Shots:

  • The approval is based on the P-II innovaTV 204 clinical trials evaluating tisotumab vedotin in 101 patients with r/mCC who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including one prior Pt-based CT regimen
  • The results showed an ORR (24%) as assessed by IRC using RECIST v1.1 criteria, m-DoR (8.3mos.)
  • Tivdak is the first approved ADC that directed to TF and Seagen’s ADC technology that utilizes a protease-cleavable linker & covalently attaches the microtubule-disrupting agent MMAE to Ab. The P-III innovaTV 301clinical trial of Tivdak is underway that is intended to support global registrations

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