ImmunityBio, Inc. (NASDAQ:IBRX) is making significant strides in the development and regulatory approval of Anktiva (nogapendekin alfa inbakicept) for the treatment of non-muscle invasive bladder cancer (NMIBC). The company has completed regulatory filings in the European Union (EU) and the United Kingdom (UK) for Anktiva in combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors.
Regulatory Milestones in Europe and the US
The acceptance of ImmunityBio’s applications by regulatory bodies in the EU and the UK is anticipated by the fourth quarter of 2025, with final decisions expected by 2026. Approval from the European Medicines Agency would allow commercialization in 27 EU countries, Iceland, Norway, and Liechtenstein. In the United States, Anktiva, combined with BCG, received FDA approval in April 2024 for the same indication. The U.S. launch has gained traction, with the therapy now broadly available through commercial and government insurance programs, covering over 240 million lives.
Clinical Data and Outcomes
ImmunityBio is also preparing to submit a supplemental Biologics License Application (sBLA) in 2025 for Anktiva + BCG to treat BCG-unresponsive NMIBC in the papillary indication. Clinical data has demonstrated promising results, with a disease-free rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months. Furthermore, 93% of patients avoided cystectomy (bladder removal) after a median follow-up of 20.7 months.
Addressing BCG Shortage
To address the shortage of BCG, ImmunityBio is collaborating with the Serum Institute of India and plans a regulatory submission for an alternative source of BCG in the first quarter of 2025. The Serum Institute’s GMP capacity to manufacture large-scale volumes of BCG, already tested for safety and efficacy in clinical trials in Europe, aims to alleviate the supply constraints.
Market Impact
The Centers for Medicare & Medicaid Services in the United States has assigned a unique, permanent Healthcare Common Procedure Coding System J-code for Anktiva, which is expected to simplify the reimbursement process and increase patient accessibility. This development, along with the potential approvals in Europe, underscores ImmunityBio's commitment to expanding treatment options for bladder cancer patients.
