FDA — authorised 20 December 2019
- Application: BLA761139
- Marketing authorisation holder: DAIICHI SANKYO
- Status: supplemented
🇺🇸 Enhertu in United States
FDA authorised Enhertu on 20 December 2019
Marketing authorisations
FDA
- Status: approved
Enhertu 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 Enhertu approved in United States?
Yes. FDA authorised it on 20 December 2019; FDA has authorised it.
Who is the marketing authorisation holder for Enhertu in United States?
DAIICHI SANKYO holds the US marketing authorisation.