The FDA has granted full approval to Pfizer and Genmab’s antibody-drug conjugate Tivdak for the treatment of recurrent or metastatic cervical cancer. Originally developed under a partnership between Seagen and Genmab, Tivdak is an antibody-drug conjugate that targets the cell surface tissue factor protein, which is an important part of the blood coagulation cascade.
Pfizer took over Seagen’s half of the deal when it bought the cancer-focused biotech in March 2023 for $43B. Based on a 24% objective response rate from the Phase II innovaTV 204 trial, the FDA granted Tivdak its accelerated approval in September 2021. The mid-stage study also showed a median duration of response of 8.3 months.