🇺🇸 TRASTUZUMAB EMTANSINE in United States

FDA authorised TRASTUZUMAB EMTANSINE on 26 March 2026

Marketing authorisation

FDA — authorised 26 March 2026

Application: BLA125427
Marketing authorisation holder: GENENTECH
Indication: Labeling
Status: approved

The FDA approved TRASTUZUMAB EMTANSINE, a cancer medication, for its approved indication. This approval was granted to Genentech, the marketing authorisation holder, following a standard expedited pathway. The approval date was 26 March 2026, with application number BLA125427.

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TRASTUZUMAB EMTANSINE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is TRASTUZUMAB EMTANSINE approved in United States?

Yes. FDA authorised it on 26 March 2026.

Who is the marketing authorisation holder for TRASTUZUMAB EMTANSINE in United States?

GENENTECH holds the US marketing authorisation.