FDA — authorised 22 December 2022
- Application: BLA761263
- Marketing authorisation holder: GENENTECH INC
- Local brand name: LUNSUMIO
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 LUNSUMIO in United States
FDA authorised LUNSUMIO on 22 December 2022
Marketing authorisations
FDA
- Status: approved
LUNSUMIO 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 LUNSUMIO approved in United States?
Yes. FDA authorised it on 22 December 2022; FDA has authorised it.
Who is the marketing authorisation holder for LUNSUMIO in United States?
GENENTECH INC holds the US marketing authorisation.