🇺🇸 Polatuzumab in United States

FDA authorised Polatuzumab on 18 March 2026

Marketing authorisation

FDA — authorised 18 March 2026

  • Application: BLA761121
  • Marketing authorisation holder: GENENTECH
  • Indication: Labeling
  • Status: approved

The FDA approved Polatuzumab for its approved indication on 18 March 2026. The marketing authorization was granted to GENENTECH, the marketing authorisation holder. This approval was based on a standard application pathway.

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Polatuzumab 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 Polatuzumab approved in United States?

Yes. FDA authorised it on 18 March 2026.

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

GENENTECH holds the US marketing authorisation.