The Food and Drug Administration has granted accelerated approval to tisotumab vedotin-tftv (Tivdak) to treat adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Tisotumab vedotin-tftv is a tissue factor-directed antibody and microtubule inhibitor conjugate. It is a bound combination of a monoclonal antibody with a potent antimitotic, monomethyl auristatin E (MMAE). Tissue factor is the primary initiator of the extrinsic blood coagulation cascade. Tisotumab vedotin-tftv's label states that the anticancer activity of tisotumab vedotin-tftv is likely "due to the binding of the ADC [antibody drug conjugate] to TF [tissue factor] expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death."

Approval was granted based on data from an open-label, multicenter, single-arm clinical trial of 101 patients. The main efficacy outcome measures were confirmed objective response rate (ORR) and duration of response. The ORR was 24% with a median response duration of 8.3 months. The drug was approved based on tumor response rate. Verification of clinical benefit is required in additional trials.

The most common laboratory adverse effects of tisotumab vedotin-tftv were decreased hemoglobin, lymphocytes, and leukocytes; increased creatinine and prothrombin international normalized ratio; and prolonged activated partial thromboplastin time. The most common nonlaboratory adverse effects were fatigue, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival adverse reactions, hemorrhage, dry eye, diarrhea, and rash. Ocular adverse effects occurred in 60% of patients across clinical trials. The labeling contains a boxed warning of ocular toxicity that can include changes in vision, severe vision loss, and corneal ulceration.

To minimize the risk of ocular toxicity from tisotumab vedotin-tftv, nurses should read the product's labeling carefully and follow the guidelines for premedication and required eye care. An ophthalmic examination should be conducted at baseline, prior to each dose, and as clinically indicated. Dosage adjustments may be needed depending on the severity of adverse effects.

Nurses need to use precaution when handling tisotumab vedotin-tftv, as it is considered a hazardous drug and requires adherence to procedures for special handling and disposal. The drug is administered as an intravenous infusion. The product's labeling includes specific guidance for reconstitution, dilution, and administration.

For complete prescribing information for tisotumab vedotin-tftv, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761208Orig1s000lbledt.p.