🇺🇸 Tisotumab Vedotin in United States

FDA authorised Tisotumab Vedotin on 20 September 2021

Marketing authorisations

FDA — authorised 20 September 2021

  • Application: BLA761208
  • Marketing authorisation holder: SEAGEN
  • Local brand name: TIVDAK
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Status: approved

Tisotumab Vedotin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Tisotumab Vedotin approved in United States?

Yes. FDA authorised it on 20 September 2021; FDA has authorised it.

Who is the marketing authorisation holder for Tisotumab Vedotin in United States?

SEAGEN holds the US marketing authorisation.