The FDA has granted accelerated approval to the first-in-class antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) from Genmab and Seagen to treat adults with recurrent or metastatic cervical cancer. Specifically, the approval covers cancer with disease progression on or after chemotherapy.
The drug targets protein tissue factor (TF), which is abnormally expressed in cervical cancer.
Historically, physicians have had few options for recurrent or metastatic cervical cancer patients with disease progression.
FDA granted accelerated approval based on data from the Phase 2 innovaTV 204 clinical study, which evaluated 101 patients. The drug had a 24% confirmed objective response rate, based on an analysis from an independent review committee.
The label for Tivdak will include a boxed warning detailing the risk of ocular toxicity. The label will also describe common adverse reactions, including decreased hemoglobin and lymphocytes, fatigue, nausea, peripheral neuropathy and alopecia.
Ttisotumab clinical trials for are also underway for locally advanced solid tumors (in Japan), metastatic solid tumors and platinum-resistant ovarian cancer.
FDA developed the Accelerated Approval Program in 1992. In the program, continued approval may rely on positive results from confirmatory trials.