FDA — authorised 15 June 2023
- Marketing authorisation holder: GENENTECH INC
- Status: approved
🇺🇸 Columvi in United States
FDA authorised Columvi on 15 June 2023
Marketing authorisations
FDA — authorised 27 October 2025
- Application: BLA761309
- Marketing authorisation holder: GENENTECH INC
- Indication: Labeling
- Status: approved
The FDA approved Columvi, a drug developed by GENENTECH INC, on 2025-10-27. This approval was granted under the standard expedited pathway. Columvi is indicated for labeling, but the specific local brand name is not reported. The application number for this approval is BLA761309.
Columvi 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 Columvi approved in United States?
Yes. FDA authorised it on 15 June 2023; FDA authorised it on 27 October 2025.
Who is the marketing authorisation holder for Columvi in United States?
GENENTECH INC holds the US marketing authorisation.