🇺🇸 Kyprolis in United States

FDA authorised Kyprolis on 20 July 2012 · 8,132 US adverse-event reports

Marketing authorisations

FDA — authorised 20 July 2012

  • Application: NDA202714
  • Marketing authorisation holder: ONYX PHARMS AMGEN
  • Status: supplemented

FDA

  • Status: approved

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. Off Label Use — 1,400 reports (17.22%)
  2. Plasma Cell Myeloma — 1,123 reports (13.81%)
  3. Fatigue — 1,114 reports (13.7%)
  4. Death — 946 reports (11.63%)
  5. Dyspnoea — 670 reports (8.24%)
  6. Nausea — 649 reports (7.98%)
  7. Diarrhoea — 606 reports (7.45%)
  8. Pneumonia — 573 reports (7.05%)
  9. Pyrexia — 537 reports (6.6%)
  10. Asthenia — 514 reports (6.32%)

Source database →

Kyprolis 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 Kyprolis approved in United States?

Yes. FDA authorised it on 20 July 2012; FDA has authorised it.

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

ONYX PHARMS AMGEN holds the US marketing authorisation.