FDA — authorised 20 December 2019
- Marketing authorisation holder: DAIICHI SANKYO
- Status: approved
🇺🇸 Enhertu in United States
FDA authorised Enhertu on 20 December 2019
Marketing authorisations
FDA — authorised 15 December 2025
- Application: BLA761139
- Marketing authorisation holder: DAIICHI SANKYO
- Indication: Efficacy
- Status: approved
The FDA approved Enhertu, a drug developed by Daiichi Sankyo, for its approved indication. This approval was granted on 15 December 2025, following a standard expedited pathway. Enhertu is a treatment option for patients with the approved indication.
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 authorised it on 15 December 2025.
Who is the marketing authorisation holder for Enhertu in United States?
DAIICHI SANKYO holds the US marketing authorisation.