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FDA: Accelerated approval for Genmab and Seagen’s TIVDAK

Published on 21/09/21 at 08:52am

The FDA has granted accelerated approval for Genmab and Seagen’s TIVDAK (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The placement of TIVDAK into the FDA’s Accelerated Approval Program was based on data from the Phase II innovaTV 204 trial that evaluated tisotumab vedotin in 101 patients.

Results from the trial showed a 24% confirmed objective response rate as assessed by an independent review committee using Response Evaluation Criteria in Solid Tumors v1.1 criteria. The median duration of response was 8.3 months.

Robert Coleman, Chief Scientific Officer at Genmab and US Oncology Research and lead investigator of the innovaTV 204 clinical trial, said: “Once recurrent or metastatic cervical cancer progresses, there is a need for more options for these patients.

“This is an important development for patients with recurrent or metastatic cervical cancer.”

It is estimated that in 2021, more than 14,480 new cases of invasive cervical cancer will be diagnosed in the US, and 4,290 women will die from the disease. Cervical cancer remains one of the leading causes of cancer death in women globally, with over 311,000 women dying of the disease in 2018.

TIVDAK is an ADC composed of Genmab’s human monoclonal antibody directed to tissue factor and Seagen’s ADC technology that utilises a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E to the antibody.

Nonclinical data suggests that the anticancer activity of TIVDAK is due to the binding of the ADC to TF expressing cancer cells, followed by internalisation of the ADC-TF complex, and release of MMAE via proteolytic cleavage.

MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, TIVDAK also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

Jan van de Winkel, Chief Executive Officer of Genmab, said: “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”.

A Biologics License Application (BLA) for TIVDAK was submitted in February 2021 and accepted with Priority Review in April 2021. The submission was based on the results of the innovaTV 204 trial.

The FDA’s Accelerated Approval Program allows for approval of a medicine based on a surrogate endpoint that is reasonably likely to predict clinical benefit, if the medicine fills an unmet medical need for a serious condition. A global, randomised Phase III clinical trial (innovaTV 301) is underway and is also intended to support global registrations.

Kat Jenkins

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