🇺🇸 Datroway in United States

FDA authorised Datroway on 17 January 2025

Marketing authorisations

FDA — authorised 17 January 2025

  • Application: BLA761394
  • Marketing authorisation holder: DAIICHI SANKYO INC
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA approved Datroway, a new molecular entity, on 17 January 2025, under the standard expedited pathway. The marketing authorisation holder is DAIICHI SANKYO INC. The approval was granted for the treatment of a specific medical condition, but the exact indication is not specified in the available data. Further information on the approved indication and local brand name is not provided.

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FDA — authorised 15 December 2025

  • Application: BLA761139
  • Marketing authorisation holder: DAIICHI SANKYO
  • Indication: Efficacy
  • Status: approved

The FDA approved Datroway, a drug developed by Daiichi Sankyo, for its approved indication. The approval was granted on 15 December 2025, following a standard expedited pathway. The application number for this approval is BLA761139.

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FDA

  • Marketing authorisation holder: DAIICHI SANKYO
  • Status: approved

Datroway 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 Datroway approved in United States?

Yes. FDA authorised it on 17 January 2025; FDA authorised it on 15 December 2025; FDA has authorised it.

Who is the marketing authorisation holder for Datroway in United States?

DAIICHI SANKYO INC holds the US marketing authorisation.