On September 20, 2021, the FDA accelerated the approval of tisotumab vedotin-tftv (Tivdak; Seagen), a tissue factor–directed antibody and microtubule inhibitor conjugate, for the treatment of women with recurrent or metastatic cervical cancer whose disease progressed during or after chemotherapy.
This approval was based on an open-label, multicenter, single-arm clinical trial of 101 patients with recurrent or metastatic cervical cancer who had received ≤2 systemic regimens that included ≥1 platinum-based chemotherapy regimens in the recurrent or metastatic setting. The patients received intravenous infusion of tisotumab vedotin 2 mg/kg every 3 weeks until disease progression or unacceptable adverse events.
The main efficacy measures were confirmed objective response rate (ORR) and duration of response (DOR). The ORR was 24% (95% confidence interval [CI], 15.9%-33.3%), with a median DOR of 8.3 months (95% CI, 4.2-not reached).
The most common (≥25%) adverse events were reduced hemoglobin, fatigue, reduced lymphocytes, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival adverse reactions, hemorrhage, reduced leukocytes, increased creatinine, dry eye, increased prothrombin international normalized ratio, prolonged activated partial thromboplastin time, diarrhea, and rash. The prescribing information of tisotumab vedotin includes a boxed warning about ocular adverse events.
Continued approval for this indication may be contingent on confirmatory data from a clinical trial.