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The FDA granted accelerated approval to tisotumab vedotin-tftv (Tivdak), a first-in-class drug, for the treatment of patients with recurrent or metastatic cervical cancer, drugmakers .

Tisotumab vedotin, a tissue factor-directed antibody and microtubule inhibitor conjugate, is indicated for women whose disease progressed on or following chemotherapy.

Approval was based on findings from innovaTV 204, a phase II trial that included 101 cervical cancer patients who had been treated with a maximum of two prior systemic regimens for their recurrent or metastatic disease.

Per independent review committee, the confirmed objective response rate (ORR) with tisotumab vedotin was 24% (95% CI 15.9-33.3%), with a median duration of response of 8.3 months among responders (95% CI 4.2 to not reached). Median overall survival in the study was just over 12 months.

"Once recurrent or metastatic cervical cancer progresses, there is a need for more options for these patients," said lead study investigator Robert L. Coleman, MD, of U.S. Oncology Research in Woodlands, Texas. "This is an important development for patients with recurrent or metastatic cervical cancer."

A boxed warning in the labeling of tisotumab vedotin includes the risk for ocular toxicity. Other warnings include the risks for embryo-fetal toxicity, hemorrhage, peripheral neuropathy, and pneumonitis.

Common adverse events (AEs) in the trial included decreased hemoglobin (52%), lymphocytes (42%), or leukocytes (30%); fatigue (50%); nausea 41%); peripheral neuropathy, alopecia, and epistaxis (39% for each); conjunctival toxicities (37%); hemorrhage (32%); increased creatinine (29%) or prothrombin international normalized ratio (26%); dry eye (29%); prolonged activated partial thromboplastin time (26%); diarrhea (25%); and rash (25%). In the trial, 28% of women had at least one grade 3 or higher treatment-related AE, and 13% discontinued treatment due to toxicity.

Under the accelerated approval pathway, continued approval of tisotumab vedotin may be contingent upon confirmatory trials demonstrating clinical benefit.

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