🇺🇸 Blenrep in United States

FDA authorised Blenrep on 23 October 2025

Marketing authorisation

FDA — authorised 23 October 2025

  • Application: BLA761440
  • Marketing authorisation holder: GLAXOSMITHKLINE LLC
  • Indication: Type 2 - New Active Ingredient
  • Status: approved

The FDA granted marketing authorisation to GlaxoSmithKline LLC for Blenrep, a new active ingredient for the treatment of multiple myeloma. This approval was based on a standard application pathway. Blenrep is a monoclonal antibody that targets the BCMA protein, which is involved in the growth and survival of cancer cells.

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Blenrep 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 Blenrep approved in United States?

Yes. FDA authorised it on 23 October 2025.

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

GLAXOSMITHKLINE LLC holds the US marketing authorisation.