FDA — authorised 14 November 2019
- Application: NDA213217
- Marketing authorisation holder: BEONE MEDICINES USA
- Indication: Labeling
- Status: approved
🇺🇸 Brukinsa in United States
FDA authorised Brukinsa on 14 November 2019 · 1,667 US adverse-event reports
Marketing authorisations
FDA — authorised 10 June 2025
- Application: NDA218785
- Marketing authorisation holder: BEONE MEDICINES USA
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved Brukinsa, a new dosage form, for a specific indication on 10 June 2025. The marketing authorisation was granted to BEONE MEDICINES USA under the standard expedited pathway. This approval is based on the NDA218785 application.
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.
- Window: 19 April 2025 – 19 April 2026
- Total reports: 1,667
Most-reported reactions
- Off Label Use — 414 reports (24.84%)
- Contusion — 183 reports (10.98%)
- Disease Progression — 178 reports (10.68%)
- Fatigue — 155 reports (9.3%)
- Rash — 140 reports (8.4%)
- Death — 133 reports (7.98%)
- Myelosuppression — 130 reports (7.8%)
- White Blood Cell Count Decreased — 118 reports (7.08%)
- Platelet Count Decreased — 110 reports (6.6%)
- Diarrhoea — 106 reports (6.36%)
Brukinsa 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 Brukinsa approved in United States?
Yes. FDA authorised it on 14 November 2019; FDA authorised it on 10 June 2025.
Who is the marketing authorisation holder for Brukinsa in United States?
BEONE MEDICINES USA holds the US marketing authorisation.