Is Tisotumab vedotin approved by the US FDA?

Drugs@FDA lists 1 application product line for Tisotumab vedotin, including TIVDAK (Prescription).

Is Tisotumab vedotin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tisotumab vedotin: Tivdak.

Are there safety signals or safety updates for Tisotumab vedotin?

US FDA: 1 entry (latest 2025-11-12).

Active substance

Tisotumab vedotin

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TIVDAK	40MG	injectable · injection	SEAGEN	Prescription	20 Sep 2021

EMA European Union — centrally authorised medicines

Tivdak Genmab A/S · Authorised · authorised 28 Mar 2025 · ATC L01FX23

Therapeutic indication (EMA)

Tivdak as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy (see section 5.1).

Safety signals and safety-related labeling changes

US FDA 12 Nov 2025 TIVDAK — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for tisotumab vedotin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.