🇪🇺 N-803 in European Union

EMA authorised N-803 on 16 February 2026

Marketing authorisation

EMA — authorised 16 February 2026

  • Application: EMEA/H/C/006622
  • Marketing authorisation holder: Immunitybio Ireland Limited
  • Local brand name: Anktiva
  • Indication: Anktiva in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
  • Pathway: conditional
  • Status: approved

On 16 February 2026, the European Medicines Agency (EMA) granted marketing authorisation for Anktiva (N-803) in the European Union. Anktiva is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and/or papillary tumours. This approval was granted under the conditional approval pathway.

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N-803 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 European Union

Frequently asked questions

Is N-803 approved in European Union?

Yes. EMA authorised it on 16 February 2026.

Who is the marketing authorisation holder for N-803 in European Union?

Immunitybio Ireland Limited holds the EU marketing authorisation.