The U.S. FDA has converted the accelerated approval of Pfizer and Genmab's ADC, Tivdak, to full approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
The full approval is based on results from the global phase 3 innovaTV 301 trial, in which Tivdak met its primary endpoint of overall survival in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy. Tivdak also met secondary endpoints of progression-free survival and a confirmed objective response rate. It's now the first ADC with demonstrated overall survival data to be granted full FDA approval in this patient population.
Tivdak is an antibody-drug conjugate composed of Genmab’s human monoclonal antibody directed to tissue factor and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody.
The drug, which was co-developed by Genmab and Seagen, was granted accelerated approval in the U.S. in September 2021. Pfizer then picked up the asset, along with three other approved cancer ADCs, in its $43 billion acquisition of Seagen last year.
