ImmunityBio Shares Updates On Marketing Authorization Application For Non-Muscle Invasive Bladder Cancer With CIS

ImmunityBio, Inc. announced that it had completed the submission of the marketing authorisation application (MAA) for its cancer therapy ANKTIVA® (nogapendekin alfa inbakicept) combined with Bacillus Calmette-Guérin (BCG). The applications were submitted to the European Medicines Agency (EMA) and the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). This treatment targets adults with non-muscle invasive bladder cancer (NMIBC), which don't respond to BCG alone, specifically those with carcinoma in situ (CIS), with or without papillary tumours. 

The EMA’s review will cover 27 EU countries, Iceland, Norway, and Liechtenstein; simultaneously, the MHRA will examine the MAA in the UK. Both agencies are expected to complete their reviews by the fourth quarter of 2025, with potential approvals by 2026. ImmunityBio is actively working with regulators to address questions during this process.

Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, commented, “The submission of our applications to EMA and MHRA represents a significant milestone in our efforts to address this critical need and improve patient outcomes globally.”

Meanwhile, ANKTIVA has gained significant attraction in the U.S. since its launch for NMIBC CIS. It is now widely available and supported by commercial and government insurance plans. The therapy has also received a permanent HCPCS J-code (J9028) from Medicare and Medicaid (CMS), making it easier for healthcare providers to bill for the treatment. Over 240 million people in the U.S. are now covered by commercial and governmental insurance for ANKTIVA.