FDA — authorised 10 June 2019
- Marketing authorisation holder: GENENTECH
- Status: approved
🇺🇸 Polivy in United States
FDA authorised Polivy on 10 June 2019
Marketing authorisations
FDA — authorised 10 June 2019
- Application: BLA761121
- Marketing authorisation holder: GENENTECH
- Local brand name: POLIVY
- Indication: POWDER — INTRAVENOUS
- Status: approved
The FDA approved Polivy, a product of Genentech, for its approved indication. This approval was granted on March 18, 2026, under the standard expedited pathway. Polivy's application number is BLA761121.
Polivy 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 Polivy approved in United States?
Yes. FDA authorised it on 10 June 2019; FDA authorised it on 10 June 2019.
Who is the marketing authorisation holder for Polivy in United States?
GENENTECH holds the US marketing authorisation.