FDA — authorised 28 May 2021
- Marketing authorisation holder: AMGEN INC
- Status: approved
🇺🇸 Lumakras in United States
FDA authorised Lumakras on 28 May 2021
Marketing authorisations
FDA — authorised 24 April 2023
- Application: NDA214665
- Marketing authorisation holder: AMGEN INC
- Indication: Labeling
- Status: approved
Lumakras 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 Lumakras approved in United States?
Yes. FDA authorised it on 28 May 2021; FDA authorised it on 24 April 2023.
Who is the marketing authorisation holder for Lumakras in United States?
AMGEN INC holds the US marketing authorisation.