🇺🇸 Perjeta in United States

FDA authorised Perjeta on 8 June 2012

Marketing authorisations

FDA — authorised 8 June 2012

Application: BLA125409
Marketing authorisation holder: GENENTECH
Local brand name: PERJETA
Indication: VIAL — SINGLE-USE
Status: approved

The FDA approved Perjeta, manufactured by Genentech, for the treatment of HER2-positive breast cancer. This approval was granted under the standard expedited pathway. The application number for this approval is BLA125409.

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FDA — authorised 29 June 2020

Application: BLA761170
Marketing authorisation holder: GENENTECH INC
Indication: Type 4 - New Combination
Status: approved

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Perjeta 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 Perjeta approved in United States?

Yes. FDA authorised it on 8 June 2012; FDA authorised it on 29 June 2020.

Who is the marketing authorisation holder for Perjeta in United States?

GENENTECH holds the US marketing authorisation.