In the randomized, open-label, phase 3 innovaTV 301 trial, tisotumab vedotin significantly extended both overall survival (11.5 months versus 9.5 months) and progression-free survival (4.2 months versus 2.9 months), compared…
A population-based analysis of national mortality data in England (2001-2024) found a substantial reduction in cervical cancer mortality among women aged 20-29 associated with high uptake of England's HPV vaccination…
In the randomized, open-label, phase 3 innovaTV 301 trial, tisotumab vedotin significantly extended both overall survival (11.5 months versus 9.5 months) and progression-free survival (4.2 months versus 2.9 months), compared…
A population-based analysis of national mortality data in England (2001-2024) found a substantial reduction in cervical cancer mortality among women aged 20-29 associated with high uptake of England's HPV vaccination…
✓ Primary source cited
Last reviewed
FDA Approvals
Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.
Adults with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens (including chemotherapy, with or without bevacizumab or an anti-PD-(L)1 agent), randomized to tisotumab vedotin or investigator's choice of chemotherapy.
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
innovaTV 301/ENGOT-cx12/GOG-3057 trial results: tisotumab vedotin versus chemotherapy in recurrent or metastatic cervical cancer (Annals of Oncology). DOI 10.1016/j.annonc.2023.10.029.
Women aged 20-29 in England, tracked via national population-based cervical cancer mortality data from 2001 to 2024, spanning cohorts vaccinated and not vaccinated under England's HPV immunisation program (introduced 2008).
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Prevention of cervical, vulvar, vaginal, and anal cancers and precancerous/dysplastic lesions caused by specific HPV types (Gardasil 9's original approved indication) -- cited as evidence the underlying vaccine family is licensed and non-investigational, NOT as an FDA review of the England mortality analysis this record reports.
Decision date
2014-12-10
Access notes
Cited for regulatory-status context only -- this record's actual claims are about a separate, later England-specific mortality analysis, not this original US approval.
Cervical cancer mortality trends following HPV vaccination in England, 2001-24: an analysis of population-based mortality data (The Lancet). DOI 10.1016/S0140-6736(26)00918-9.
CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.