EMA recommends conditional approval of Anktiva in BCG-unresponsive NMIBC

The European Medicines Agency (EMA) has recommended granting conditional marketing authorization to nogapendekin alfa inbakicept (Anktiva) in combination with BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), ImmunityBio announced in a news release.¹

According to the company, conditional marketing approval is granted to medicines when the benefits of early access to the therapy outweigh the risks associated with the data, in this case, from a single-arm trial. The decision will now move to the European Commission, which will decide on final approval for marketing authorization in the European Union.

Nogapendekin alfa inbakicept was approved in the US in April 2024 and in the United Kingdom in July 2025 for this indication.

“ANKTIVA represents an important evolution in the treatment of NMIBC CIS, strengthening the immune response and improving the durability of BCG,” said Patrick Soon-Shiong, MD, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, in the news release.¹ “Hundreds of patients in the US are already experiencing the benefits of this therapy, and our goal is to make it available to patients in Europe and other parts of the world as quickly and responsibly as possible, to ensure avoidance of a radical cystectomy.”

Notably, unlike the US where only 1 substrain of BCG is available, Europe has access to 6 approved substrains.

“Six BCG strains are available in Europe for use in combination with ANKTIVA, and we are expeditiously developing our recombinant BCG candidate to address ongoing BCG shortages in the US and help ensure that all eligible patients can benefit from this treatment,” said Richard Adcock, President and CEO of ImmunityBio, in the news release.¹

The positive recommendation was based on data from a single-arm trial (NCT03022825) of 100 adult patients with BCG-unresponsive NMIBC CIS with or without papillary disease.² Participants in the study received nogapendekin alfa inbakicept in combination with BCG.

Overall, the trial demonstrated a complete response rate of 71% (95% CI, 61.1 to 79.6), with responses ranging up to more than 54 months. The average duration of response was 27 months. Further, among responders to treatment, the complete response rate was 66% at 12 months and 42% at 24 months.

As part of the recommendation for conditional approval, ImmunityBio will continue to submit long-term safety and efficacy data from the trial to the EMA.

“We are looking forward to finalizing plans to bring our innovative treatment to qualified EU patients,” concluded Adcock in the news release.¹ “With the United States’ new Most-Favored-Nation Prescription Drug Pricing policy now in effect, we are thoughtfully assessing our approach to launching in Europe to ensure broad, equitable, and sustainable access.”

REFERENCES

1. ImmunityBio receives conditional marketing authorization recommendation from the European Medicines Agency for ANKTIVA® with BCG for non-muscle invasive bladder cancer carcinoma in situ—A first in Europe. News release. ImmunityBio. December 12, 2025. Accessed December 12, 2025. https://immunitybio.com/immunitybio-receives-conditional-marketing-authorization-recommendation-from-the-european-medicines-agency-for-anktivao-with-bcg-for-non-muscle-invasive-bladder-cancer-carcinoma-in-situ-a-firs/

2. Chang SS, Chamie K, Kramolowsky E, et al. An update on QUILT-3.032: Complete responses to N-803 plus BCG therapy in BCG-unresponsive bladder carcinoma in situ (CIS) with or without Ta/T1 papillary disease. J Urol. 2025;213(5S):e392. doi:10.1097/01.JU.0001109848.08748.9e.12