🇺🇸 DURVALUMAB in United States

FDA authorised DURVALUMAB on 18 November 2020 · 3,173 US adverse-event reports

Marketing authorisation

FDA — authorised 18 November 2020

  • Application: BLA761069
  • Marketing authorisation holder: ASTRAZENECA UK LTD
  • Indication: Labeling
  • 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. Death — 760 reports (23.95%)
  2. Malignant Neoplasm Progression — 452 reports (14.25%)
  3. Pyrexia — 322 reports (10.15%)
  4. Pneumonitis — 306 reports (9.64%)
  5. Off Label Use — 271 reports (8.54%)
  6. Diarrhoea — 260 reports (8.19%)
  7. Pneumonia — 217 reports (6.84%)
  8. Asthenia — 199 reports (6.27%)
  9. Anaemia — 194 reports (6.11%)
  10. Colitis — 192 reports (6.05%)

Source database →

DURVALUMAB 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 DURVALUMAB approved in United States?

Yes. FDA authorised it on 18 November 2020.

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

ASTRAZENECA UK LTD holds the US marketing authorisation.