FDA Grants Accelerated Approval to Tisotumab Vedotin in Recurrent Or Metastatic Cervical Cancer


Tisotumab vedotin may now be used to treat patients with recurrent or metastatic cervical cancer after the FDA's decision to grant the agent an accelerated approval.

Accelerated approval has been granted to tisotumab vedotin-tftv (Tivdak) for the treatment of patients with recurrent or metastatic cervical cancer following disease progression on or after chemotherapy, according to the companies responsible for developing the agent, Seagen Inc. and Genmab A/S.

The decision from the agency is supported by data from the single-arm phase 2 innovaTV 204 trial (NCT03438396) of tisotumab vedotin which resulted in a 24% (95% CI, 15.9%-33.3%) confirmed overall response rate by independent review committee in previously treated, recurrent or metastatic cervical cancer.

“Tivdak’s approval as a monotherapy in the U.S. is an important milestone for women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, as they are in need of a new treatment option and we look forward to making it available to them,” Jan van de Winkel, PhD, chief executive officer of Genmab, said in a statement. “The journey towards the approval of Tivdak started nearly 2 decades ago with innovative research by scientists at Genmab and Seagen and reflects on our purpose of making an impact in the lives of [patients with] cancer and their families. Today’s announcement marks Genmab’s evolution into a fully integrated biotechnology company and we would like to thank patients, caregivers, investigators, and our collaborators for their participation in our clinical studies.”

Results from the trial that were previously presented at the European Society for Medical Oncology 2020 Virtual Congress highlighted a 7% complete response rate and a 17% partial response rate, as well as a median duration of response (DOR) was 8.3 months (95% CI, 4.2–not reached).

The biologics license application for tisotumab vedotin-tftv in this indication was submitted in February 2021 and granted priority review in April 2021. Continuous approval may be contingent upon verification from additional clinical data. The phase 3 innovaTV 301 trial (NCT04697628) comparing tisotumab vedotin-tftc vs investigators choice of chemotherapy in patients with recurrent or metastatic cervical cancer is currently ongoing.


Seagen and Genmab announce FDA accelerated approval for TIVDAK™ (tisotumab vedotin-tftv) in previously treated recurrent or metastatic cervical cancer. News release. Seagen Inc. and Genmab A/S. September 20, 2021. Accessed September 20, 2021. https://bwnews.pr/2XJLowv

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