Tivdak (tisotumab vedotin)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tisotumab vedotin
- Company
- Genmab A/S
- Status
- Authorised
- Therapeutic area
- Uterine Cervical Neoplasms
- CHMP opinion
- Thu 30 Jan 2025
- EU approval
- Fri 28 Mar 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005363
- ATC
- L01FX23
- Official record
- www.ema.europa.eu
Indication
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).
Regulatory milestones
No milestones recorded in the last year.
Follow Tivdak
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.