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# Pfizer Gets Traditional Approval for Tivdak
- URL: https://www.fdaweb.com/pfizer-gets-traditional-approval-for-tivdak/
- Published: 2024-04-30T12:00:00.000Z
- Updated: 2026-09-14T14:29:37.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156885

FDA has granted Pfizer traditional approval for its previously accelerated-approved Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Approval was based on efficacy data from the innovaTV 301 (NCT04697628), an open-label, active-controlled trial that enrolled 502 patients with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens, including chemotherapy with or without bevacizumab and/or an anti-PD-(L)-1 agent, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer?ref=fdaweb.com). Median overall survival was 11.5 months in the tisotumab vedotin arm and 9.5 months in the chemotherapy arm. Median progression-free survival was 4.2 months in the tisotumab vedotin arm and 2.9 months for those treated with chemotherapy, FDA says.

The most common adverse reactions (seen in 25% or more patients) were decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis, and constipation, according to the agency.