ImmunityBio Inc. (NASDAQ:IBRX) made headlines recently with a significant jump in stock price following the approval of its bladder cancer treatment, Anktiva, by the European Medicines Agency (EMA). The company saw a 7.76 percent increase on Friday, closing at $2.36 per share.
In a press release, ImmunityBio announced that the EMA had granted authorization for the sale of Anktiva in Europe. The treatment, in combination with Bacillus Calmette-Guerin (BCG), is approved for the treatment of non-muscle invasive bladder cancer (NMIBC) carcinoma in situ. This approval allows ImmunityBio to expand its reach and operations in the European market.
Anktiva is a promising therapy for bladder cancer patients who do not respond to BCG treatment. Currently, the only alternative for these patients is surgical removal of the bladder. Unlike the United States, where only one BCG substrain is approved, Europe recognizes approximately six major BCG substrains, making standard-of-care therapy more widely available across the region.
ImmunityBio’s Executive Chairman, Patrick Soon-Shiong, emphasized the importance of Anktiva in the treatment of NMIBC CIS, stating that the therapy strengthens the immune response and improves the durability of BCG. He expressed the company’s goal of making Anktiva available to patients in Europe and other parts of the world to avoid the need for radical cystectomy.
The positive recommendation from the EMA was based on a single-arm trial and a regulatory process that allows earlier access to Anktiva. ImmunityBio highlighted the benefit of immediate availability to patients, outweighing any potential risks associated with the treatment.
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In conclusion, ImmunityBio’s recent success with Anktiva in Europe marks a significant milestone for the company and the treatment of bladder cancer. With continued advancements in medical technology and research, patients may have access to more effective and innovative therapies in the future.
