FDA — authorised 4 April 2020
- Marketing authorisation holder: IMMUNOMEDICS INC
- Status: approved
🇺🇸 Trodelvy in United States
FDA authorised Trodelvy on 4 April 2020
Marketing authorisations
FDA — authorised 3 June 2022
- Application: BLA761115
- Marketing authorisation holder: IMMUNOMEDICS INC
- Indication: Labeling
- Status: approved
Trodelvy 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 Trodelvy approved in United States?
Yes. FDA authorised it on 4 April 2020; FDA authorised it on 3 June 2022.
Who is the marketing authorisation holder for Trodelvy in United States?
IMMUNOMEDICS INC holds the US marketing authorisation.