The European Medicines Agency has recommended granting a conditional marketing authorization for ImmunityBio, Inc.‘s (NASDAQ:IBRX) Anktiva (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.



The decision was based on a review of the results of a single-arm clinical trial in 100 adults with BCG-unresponsive NMIBC who received Anktiva in combination with BCG.



In 71% of patients, signs of cancer disappeared (complete response rate) with responses ranging up to 54+ months; these responses lasted for approximately 27 months on average.



Also Read: ImmunityBio Slapped With FDA Refusal To File Letter For Expanded Use Of Its Bladder Cancer Drug



The complete response rate of responders at 12 months was 66% and at 24 months was 42%.



As part of the recommendation, ImmunityBio will continue to follow up with trial participants and submit long-term safety and efficacy post-marketing results to the EMA.



Anktiva has been recommended for conditional marketing authorization, an EU regulatory mechanism that facilitates early access to medicines addressing an unmet medical need.



Bladder cancer ranks as the fifth-most common cancer and the seventh most frequently diagnosed cancer in men.



The European Association of Urology and World Bladder Cancer Patient Coalition estimate that more than 200,000 patients will be diagnosed with bladder cancer in 2025.



Approximately 75% of these patients (150,000) will have NMIBC, which is cancer that has grown only on the lining of the bladder and not into the muscle layer underneath, and is the most common form of bladder cancer.



The pathway allows the EMA to recommend marketing authorization when the benefit of a medicine’s immediate availability to patients outweighs the potential risks associated with the data, in this case, from a single-arm trial. The EMA’s opinion will now be forwarded to the European Commission for final approval of EU-wide marketing authorization.



IBRX Price Action: ImmunityBio shares were up 2.74% at $2.25 at the time of publication on Friday, according to Benzinga Pro data.



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IBRX

ImmunityBio's Anktiva, combined with BCG, receives EMA recommendation for conditional marketing authorization for BCG-unresponsive NMIBC. The decision follows a clinical trial showing a 71% complete response rate. The EMA's opinion will be forwarded to the European Commission for final approval. ImmunityBio shares rose 2.74% following the news.

ImmunityBio Moves Closer To EU Approval For Bladder Cancer Therapy