ImmunityBio, Inc. (IBRX) just got a major nod from European regulators for its bladder cancer therapy, bringing the treatment one step closer to patients across the EU.
The European Medicines Agency has recommended granting conditional marketing authorization for Anktiva (nogapendekin alfa inbakicept) when used in combination with Bacillus Calmette-Guérin (BCG). The therapy targets a particularly challenging patient population: those with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ.
The recommendation stems from a single-arm clinical trial involving 100 adults with BCG-unresponsive NMIBC who received the Anktiva-BCG combination. The results were compelling. In 71% of patients, signs of cancer disappeared entirely, with responses lasting an average of approximately 27 months. Some patients maintained their response for 54 months or longer.
Looking at durability, 66% of responders maintained their complete response at the 12-month mark, while 42% still showed complete response at 24 months.
As part of the conditional authorization framework, ImmunityBio will continue tracking trial participants and submit long-term safety and efficacy data to the EMA post-marketing. This conditional pathway exists specifically to accelerate access to medicines addressing unmet medical needs, allowing the EMA to recommend authorization when immediate patient access outweighs potential data limitations from single-arm trials.
The market need here is substantial. Bladder cancer ranks as the fifth-most common cancer overall and the seventh most frequently diagnosed cancer in men. The European Association of Urology and World Bladder Cancer Patient Coalition project more than 200,000 patients will be diagnosed with bladder cancer in 2025.
Of those diagnoses, approximately 75% (around 150,000 patients) will have NMIBC, where cancer grows only on the bladder lining without penetrating the underlying muscle layer. It's the most common form of bladder cancer.
The EMA's opinion now moves to the European Commission, which will make the final decision on EU-wide marketing authorization.
Price Action: ImmunityBio shares traded up 2.74% at $2.25 at the time of publication on Friday, according to market data.
