🇺🇸 TRASTUZUMAB DERUXTECAN in United States

FDA authorised TRASTUZUMAB DERUXTECAN on 15 December 2025 · 2,570 US adverse-event reports

Marketing authorisation

FDA — authorised 15 December 2025

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

The FDA approved TRASTUZUMAB DERUXTECAN, a cancer medication, for its approved indication. The approval was granted to DAIICHI SANKYO, the marketing authorisation holder, on 15 December 2025. This approval was made under the standard expedited pathway.

Read official source →

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Death — 415 reports (16.15%)
  2. Myelosuppression — 378 reports (14.71%)
  3. Off Label Use — 326 reports (12.68%)
  4. Nausea — 306 reports (11.91%)
  5. Fatigue — 220 reports (8.56%)
  6. Malignant Neoplasm Progression — 202 reports (7.86%)
  7. Diarrhoea — 185 reports (7.2%)
  8. Disease Progression — 184 reports (7.16%)
  9. Metastases To Central Nervous System — 180 reports (7%)
  10. Vomiting — 174 reports (6.77%)

Source database →

TRASTUZUMAB DERUXTECAN in other countries

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

Frequently asked questions

Is TRASTUZUMAB DERUXTECAN approved in United States?

Yes. FDA authorised it on 15 December 2025.

Who is the marketing authorisation holder for TRASTUZUMAB DERUXTECAN in United States?

DAIICHI SANKYO holds the US marketing authorisation.