FDA Approves Tisotumab Vedotin-tftv for Previously Treated Recurrent, Metastatic Cervical Cancer


Trial results showed a 24% confirmed objective response rate with a median duration of response of 8.3 months among patients with cervical cancer who received tisotumab vedotin-tftv.

Tisotumab vedotin-tftv (Tivdak; Genmab and Seagen) has been grated Accelerated Approval by the FDA for the treatment of previously treated recurrent or metastatic cervical cancer.

This marks the first and only approved antibody-drug conjugate for the treatment of this patient population following disease progression or after chemotherapy. The approval is based on tumor response and the durability of the response, and continued approval may be contingent upon verification of clinical benefits in confirmatory trials.

“Once recurrent or metastatic cervical cancer progresses, there is a need for more options for these patients,” said Robert L. Coleman, MD, chief scientific officer of US Oncology Network and lead investigator of the innovaTV 204 clinical trial, in a press release. “This is an important development for patients with recurrent or metastatic cervical cancer.”

Tisotumab veodtin-tftv is an antibody drug conjugate composed of a human monoclonal antibody directed to tissue factor as well as a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. According to the press release, nonclinical data suggest that the drug’s anticancer activity is due to the binding of the antibody drug conjugate to tissue factor-expressing cancer cells, followed by internalization of this complex and release of MMAE.

“Tivdak’s approval as a monotherapy in the US 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,” said Jan van de Winkel, PhD, CEO of Genmab, in the press release.

In the innovaTV 204 trial, tisotumab vedotin-tftv was evaluated in 101 patients with recurrent or metastatic cervical cancer who had received no more than 2 prior systemic regimens in the recurrent or metastatic setting, including at least 1 prior platinum-based chemotherapy regimen. According to the press release, the trial results showed a 24% confirmed objective response rate with a median duration of response of 8.3 months.

The trial is an open-label, multicenter, single-arm phase 2 trial. Researchers excluded patients if they had active ocular surface disease, any prior episode of cicatricial conjunctivitis or Stevens-Johnson syndrome, grade 2 or higher peripheral neuropathy, or known coagulation defects leading to an increased risk of bleeding.

Researchers estimate that there will be more than 14,480 new cases of invasive cervical cancer diagnosed in the United States in 2021, and 4290 women will die from the disease. Despite these statistics, there are relatively few treatment options for the disease.


Genmab and Seagen Announce FDA Accelerated Approval for Tivdak (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer. News release. Genmab; September 20, 2021. Accessed September 21, 2021. https://ir.genmab.com/news-releases/news-release-details/genmab-and-seagen-announce-fda-accelerated-approval-tivdaktm

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