FDA Grants Accelerated Approval for Recurrent or Metastatic Cervical Cancer Treatment to Tivdak

The first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy receives accelerated approval by FDA.

FDA granted accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv), a tissue factor-directed antibody and microtubule inhibitor conjugate, according to a Sept. 20, 2021, FDA press release. According to the Seagen company press release, Tivdak is the first and only approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

In the innovaTV 204 clinical trial, 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen, received Tivdak. The trial showed a 24% objective response rate with a median duration of response of 8.3 months.

Tivdak is approved under FDA’s accelerated approval program based on tumor response and the durability of the response, according to Seagen’s press release. Verification and description of clinical benefit in confirmatory trials will impact any continued approval.

“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,” said Jan van de Winkel, CEO, Genmab, in Seagen’s press release. “The journey towards the approval of TIVDAK started nearly two decades ago with innovative research by scientists at Genmab and Seagen and reflects on our purpose of making an impact in the lives of cancer patients 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.”

The biologics license application for Tivdak was submitted in Feb. 2021 and accepted with priority review in April 2021. The submission was based on the innovaTV 204 trial results.

Source: FDA, Seagen