ImmunityBio announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorization application for ANKTIVA, a treatment for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). This follows recent acceptance by the European Medicines Agency and FDA approval ten months prior. The MHRA’s validation initiates the formal review process for ANKTIVA’s potential approval in the UK.
This acceptance is crucial for bladder cancer patients in the UK who have not responded to the standard BCG treatment. It offers a new treatment option for a challenging condition and potentially expands access to this novel therapy. The rapid succession of regulatory milestones in the US, EU, and now the UK underscores the significant unmet need and the potential of ANKTIVA to address it.
ANKTIVA (nogapendekin alfa inbakicept-pmln) is a first-in-class IL-15 agonist that works by activating natural killer (NK) cells, CD8+ T cells, and memory T cells, crucial components of the immune system in fighting cancer. This approach offers a different mechanism of action than BCG, making it a valuable option for patients who haven’t responded to prior treatment. ANKTIVA is administered intravesically and has shown promising results in clinical trials.
This latest development positions ANKTIVA for potential expansion into a significant international market. Positive regulatory decisions by the MHRA and other agencies could significantly broaden patient access to ANKTIVA and strengthen ImmunityBio’s market presence, marking a pivotal step in the treatment landscape for bladder cancer. It also reinforces the company’s commitment to developing and commercializing innovative immunotherapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
