ANKTIVA (nogapendekin alfa inbakicept)
ANKTIVA (nogapendekin alfa inbakicept) is an IL-15 superagonist, an antibody-cytokine fusion protein, developed and sold by ImmunityBio. The next event is the FDA decision on ANKTIVA (supplemental application), on Jan 6, 2027 (source).
- Company
- ImmunityBio (IBRX) · Developer
- Approved
- United States, European Union, United Kingdom, United Arab Emirates
Upcoming events
Firm dates · a specific day set by the company or regulator
Next 90 days
- Jan 6in 85 daysANKTIVA · FDA decision (supplemental application) · NMIBC · BCG-unresponsive, papillary disease without CIS
Past results and milestones
- Apr 9, 2026QUILT-2.005 trial achieved full enrollment with IDMC confirmation of adequate statistical power; no additional enrollment required. Supplemental BLA submission on track for 2026. Source
- Feb 23, 2026reportedThe UK MHRA granted authorization in July 2025 for ANKTIVA in combination with BCG for BCG-unresponsive NMIBC CIS, establishing ANKTIVA's regulatory approval outside the United States. Source
- Feb 16, 2026The European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for BCG-unresponsive NMIBC with carcinoma in situ, covering all 27 EU member states plus Iceland, Liechtenstein, and Norway, based on a 71% complete response rate with 26.6 months median duration of response from the QUILT-3.032 trial. Source
- May 2, 2025On May 2, 2025, the FDA issued a Refusal to File letter for the sBLA for ANKTIVA + BCG in BCG-unresponsive NMIBC papillary disease without CIS, despite unanimous FDA guidance in January 2025 to submit the sBLA based on single-arm trial data. Source