Anktiva (nogapendekin alfa inbakicept)
- Region
- 🇪🇺 EU
- Active substance
- nogapendekin alfa inbakicept
- Company
- Immunitybio Ireland Limited
- Status
- Authorised
- Therapeutic area
- Non-Muscle Invasive Bladder Neoplasms
- CHMP opinion
- Thu 11 Dec 2025
- EU approval
- Mon 16 Feb 2026
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/006622
- ATC
- L03AC03
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
ANKTIVA: PDUFA target action date (BCG-unresponsive NMIBC with papillary disease without CIS (ANKTIVA plus BCG))
ImmunityBio, Inc. (IBRX); sBLA; status: set; "…The FDA accepted for review the Company’s supplemental Biologics License Application (sBLA) for ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC with papillary disease without CIS and assigned a PDUFA target action date of January 6, 2027 • Continued advancement across the clinical pipeline, with multiple…"; filed 2026-08-04 · source
Anktiva (nogapendekin alfa inbakicept) approved in the EU
Marketing authorisation to Immunitybio Ireland Limited; Conditional, Additional monitoring · source
Anktiva (nogapendekin alfa inbakicept): CHMP positive opinion
Immunitybio Ireland Limited; Conditional, Additional monitoring · source
Follow Anktiva
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.