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

| Ref: Business wire Image: reuter