Tivdak approval marks another ADC success for Seagen

The US FDA has approved a fourth product for Seagen and the twelfth ADC therapeutic in the form of cervical cancer drug Tivdak.

First up, it’s Seagen (previously Seattle Genetics), which received accelerated approval for Tivdak (tisotumab vedotin), an antibody drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

On a conference call discussing the approval, Seagen CEO Clay Siegall described the approval as “another significant milestone” for the firm.

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“Tivdak now becomes our fourth approved product and represents the expansion of our commercial portfolio from one product to four in less than two years. This is a remarkable achievement by the Seagen team.”

The firm’s first product, Adcetris (brentuximab vedotin), was approved in 2011. Padcev (enfortumab vedotin) became a second commercialized ADC in 2019, while Tukysa (tucatinib) was approved in 2020 in combination with chemotherapy agents for advanced forms of breast cancer.

Tivdak is composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody.

“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,” said Jan van de Winkel, CEO of Genmab.

“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.”

Tivdak is the twelfth ADC to reach approval in the US. The others, along with details surrounding the current ADC business landscape can be found as part of BioProcess Insider’s ebook ‘ADCs — Evolving Links in the Biopharmaceutical Pipeline’ published in May. Download it for free here.