🇺🇸 TUCATINIB in United States

FDA authorised TUCATINIB on 17 April 2020 · 1,878 US adverse-event reports

Marketing authorisation

FDA — authorised 17 April 2020

  • Application: NDA213411
  • Marketing authorisation holder: SEAGEN
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

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. Diarrhoea — 389 reports (20.71%)
  2. Nausea — 261 reports (13.9%)
  3. Fatigue — 228 reports (12.14%)
  4. Death — 174 reports (9.27%)
  5. Vomiting — 169 reports (9%)
  6. Metastases To Central Nervous System — 162 reports (8.63%)
  7. Off Label Use — 147 reports (7.83%)
  8. Asthenia — 119 reports (6.34%)
  9. Dehydration — 116 reports (6.18%)
  10. Disease Progression — 113 reports (6.02%)

Source database →

TUCATINIB 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 TUCATINIB approved in United States?

Yes. FDA authorised it on 17 April 2020.

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

SEAGEN holds the US marketing authorisation.