FDA — authorised 21 May 2021
- Application: BLA761210
- Marketing authorisation holder: JANSSEN BIOTECH
- Local brand name: RYBREVANT
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Amivantamab IV in United States
FDA authorised Amivantamab IV on 21 May 2021
Marketing authorisation
Amivantamab IV 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 Amivantamab IV approved in United States?
Yes. FDA authorised it on 21 May 2021.
Who is the marketing authorisation holder for Amivantamab IV in United States?
JANSSEN BIOTECH holds the US marketing authorisation.