Tisotumab vedotin approved by FDA to treat cervical cancer

Tisotumab vedotin approved by FDA to treat cervical cancer

Based on the findings of open-label, multi center, single-arm phase 2 trial, the Food and Drug Administration (FDA) has granted accelerated approval to Tisotumab vedotin for treating patients with metastatic or recurrent cervical cancer with disease progression who were either on treatment or after chemotherapy.

In this study, a total of 101 adult females with metastatic or recurrent cervical cancer were enrolled. In addition, the patients who had received treatment with no more than two prior systemic regimens in the recurrent/metastatic settings, with at least one initial platinum-based chemotherapy regimen, were included.

All the study participants were administered with tisotumab vedotin-2mg/kg intravenously once every three weeks until unacceptable toxicity or disease progression. The primary endpoints were objective response rates and duration of response. The study findings reported an accurate response rate of 24%, among which 7% and 17% of patients achieved complete and partial response, respectively. The median duration of response was estimated to be 8.3 months.

Common adverse events associated with tisotumab vedotin were fatigue, decreased leukocytes peripheral neuropathy, alopecia, conjunctival adverse reactions, bleeding, increased creatinine levels, dry eye, prolonged diarrhoea, and rash. This drug also carries a Boxed Warning regarding ocular toxicity as it can cause corneal ulceration and vision changes.

The study findings supports the use of Tisotumab vedotin, available as a lyophilized powder in a single-dose vial for reconstitution among cervical cancer patients.

SourceFDA
Linkhttps://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer
Original title of the articleFDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

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