Pfizer and Genmab’s Tivdak (tisotumab vedotin-tftv) has won full approval from the US Food and Drug Administration (FDA) to treat patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. 

The full approval is based on positive data from the Phase III innovaTV 301 clinical trial (NCT04697628). Tivdak significantly improved overall survival, showing a 30% reduction in the risk of death compared to treatment with chemotherapy. Results showed a statistically significant overall survival (OS) rate, with a median OS of 11.5 months for patients treated with Tivdak compared to 9.5 months on chemotherapy alone. 

Pfizer inherited Tivdak when it acquired Seagen in a $43bn deal in December 2023. Tivdak, a tissue-factor targeting antibody-drug conjugate (ADC) developed in collaboration with Genmab, gained accelerated approval in 2021. 

In February 2021, Genmab and Seagen submitted a biologics licence application (BLA) for Tivdak seeking accelerated approval from the FDA. The BLA was accepted with priority review in April 2021 and approved in September 2021.

The FDA’s accelerated approval of Tivdak was based on an open-label, multi-centre, single-arm Phase II clinical trial, innovaTV 301 (NCT03438396). 

ADCs combine the specificity of monoclonal antibodies with the potency of cytotoxic drugs to target and eliminate cancer cells. There has been an increase in high-profile deals in recent years as ADCs increase in popularity, with Pfizer’s acquisition of Seagen being the largest to date.  

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According to GlobalData’s Pharma Intelligence Center, Tivdak is forecast to generate $1.8bn in sales in 2030. 

GlobalData is the parent company of Pharmaceutical Technology. 

Pfizer is also seeking European approval for the ADC. In February 2024, the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for review of Tivdak for recurrent or metastatic cervical cancer.  

In the announcement accompanying the approval, Pfizer’s chief oncology officer Chris Boshoff said: “Today’s full approval by the FDA reinforces the important role of TIVDAK for these patients, as the first antibody-drug conjugate with statistically significant prolonged overall survival data.”