FDA — authorised 18 May 2016
- Application: BLA761034
- Marketing authorisation holder: GENENTECH INC
- Local brand name: TECENTRIQ
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Tecentriq in United States
FDA authorised Tecentriq on 18 May 2016
Marketing authorisations
FDA — authorised 18 October 2016
- Application: BLA761041
- Marketing authorisation holder: GENENTECH INC
- Local brand name: TECENTRIQ
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 August 2025
- Application: BLA761347
- Marketing authorisation holder: GENENTECH INC
- Indication: Labeling
- Status: approved
The FDA approved Tecentriq, a drug developed by GENENTECH INC, for its approved indication on 18 August 2025. This approval was granted through a standard expedited pathway. The application number for this approval is BLA761347.
Tecentriq 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 Tecentriq approved in United States?
Yes. FDA authorised it on 18 May 2016; FDA authorised it on 18 October 2016; FDA authorised it on 18 August 2025.
Who is the marketing authorisation holder for Tecentriq in United States?
GENENTECH INC holds the US marketing authorisation.