🇺🇸 BLINATUMOMAB in United States

FDA authorised BLINATUMOMAB on 3 May 2017 · 2,849 US adverse-event reports

Marketing authorisation

FDA — authorised 3 May 2017

  • Application: BLA125557
  • Marketing authorisation holder: AMGEN
  • 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. Acute Lymphocytic Leukaemia Recurrent — 563 reports (19.76%)
  2. Cytokine Release Syndrome — 453 reports (15.9%)
  3. Death — 296 reports (10.39%)
  4. Pyrexia — 292 reports (10.25%)
  5. Drug Ineffective — 254 reports (8.92%)
  6. Off Label Use — 230 reports (8.07%)
  7. Febrile Neutropenia — 206 reports (7.23%)
  8. Neurotoxicity — 203 reports (7.13%)
  9. Therapy Non-Responder — 185 reports (6.49%)
  10. Neutropenia — 167 reports (5.86%)

Source database →

BLINATUMOMAB 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 BLINATUMOMAB approved in United States?

Yes. FDA authorised it on 3 May 2017.

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

AMGEN holds the US marketing authorisation.