Pfizer and Genmab’s ADC Tivdak receives full FDA approval for recurrent or metastatic cervical cancer

CAR-T Digest - August 2020

30 Apr 2024: Pfizer and Genmab’s ADC Tivdak receives full FDA approval for recurrent or metastatic cervical cancer

FDA grants full approval to Pfizer and Genmab’s Tivdak for recurrent or metastatic cervical cancer post-chemotherapy
The full approval is based on positive data from the Phase III innovaTV 301 clinical trial (NCT04697628)
Tivdak demonstrated a 30% reduction in the risk of death compared to chemotherapy, with mOS of 11.5 vs 9.5 months on chemotherapy alone
Pfizer acquired Tivdak through its $43 billion acquisition of Seagen in December 2023
Accelerated approval was granted in 2021 based on a 24% objective response rate from the Phase II innovaTV 204 trial
Originally developed by Seagen and Genmab. Tivdak targets tissue factor (TF) protein, delivering monomethyl auristatin E, a toxin