FDA Approves ImmunityBio's Anktiva for Bladder Cancer, Marking Major Milestone for Soon-Shiong's Immunotherapy Approach
Key Insights
The FDA has approved ImmunityBio's lead drug Anktiva for treating a common form of bladder cancer (search), representing a significant breakthrough after years of development and regulatory challenges.
Anktiva harnesses the body's natural killer cells (search) and T-cells (search) to fight cancer, with clinical trials showing the ability to eliminate bladder cancer (search) cells for at least four years.
ImmunityBio plans to begin distributing Anktiva to healthcare providers by mid-May 2024, with the company having built a three-year stockpile of the drug during the FDA review process.
After years of development, regulatory setbacks, and significant financial investment, ImmunityBio has secured a major victory with the U.S. Food and Drug Administration's approval of its lead drug Anktiva for treating a common form of bladder cancer (search). The approval, announced on April 23, represents a pivotal moment for billionaire Patrick Soon-Shiong's Culver City-based immunotherapy company.
Novel Immunotherapy Approach
Anktiva distinguishes itself in the crowded immunotherapy landscape through its unique mechanism of action. The drug harnesses the body's own immune cells—specifically natural killer cells (search), T-cells (search), and memory T-cells—to target and eliminate cancer cells. According to Soon-Shiong, Anktiva goes beyond traditional immunotherapy approaches.
"We've changed the paradigm for looking at cancer," Soon-Shiong stated. "We're not satisfied with the endpoint free survival. We're trying to achieve the goal of cancer-free overall survival of great duration."
What sets Anktiva apart is its demonstrated ability in clinical trials to eliminate bladder cancer (search) cells in the body for at least four years. Soon-Shiong describes the drug as "the next generation of immunotherapy," claiming it is the first of its kind to "generate complete remission that's completely durable" for 47 months and longer.
Natural killer cells (search), a key component of the body's immune system targeted by Anktiva, can destroy cancer and infected cells without prior exposure to the cancer or pathogen. These cells also communicate with other immune cells to coordinate attacks against cancer cells.
Long Road to Approval
The FDA approval represents the culmination of more than a decade of work. Soon-Shiong originally formed two companies to pursue this approach: NantKWest to develop natural killer cells (search) and ImmunityBio to develop combination therapies. The companies merged in March 2021, with the resulting entity going public under the ImmunityBio name.
The path to approval faced significant obstacles. In May 2023, the FDA rejected Anktiva, citing concerns about the third-party manufacturing process and requesting additional data. This setback caused ImmunityBio's stock to plunge nearly 60%.
The company spent several months addressing these concerns before resubmitting the application in late October 2023. The FDA accepted the drug for consideration with a decision deadline of April 23, 2024, which resulted in the recent approval.
Commercial Readiness
Despite the regulatory delay, Soon-Shiong noted that the company used the additional time strategically. ImmunityBio built up a three-year stockpile of Anktiva and established a $250 million cash reserve for marketing and distribution efforts. This preparation allows the company to bring the drug to market within just three weeks of approval, rather than the several months typically required.
"The company is stable in terms of cash capabilities," Soon-Shiong stated, referencing approximately $400 million in investments made when the drug was initially rejected, with an additional $100 million forthcoming to support the commercial launch in May.
Market Impact and Future Potential
The FDA approval triggered volatility in ImmunityBio's stock, which initially surged 30% in pre-market trading following the announcement but later pared back gains. Market analysts have noted that similar drugs from competitors may enter the market in coming years, potentially limiting ImmunityBio's window for maximizing revenue from Anktiva.
Looking beyond bladder cancer (search), Soon-Shiong envisions broader applications for Anktiva. He believes the drug will serve as "a backbone" to checkpoint inhibitors, a class of immunotherapy drugs, and sees potential for targeting various cancer types regardless of their location within the body.
"This is an opportunity to use this as a fundamental platform across all tumor types," Soon-Shiong explained, highlighting the drug's potential to transform cancer treatment approaches more broadly.
The approval marks ImmunityBio's transition from a development-stage company to a commercial entity, with first revenues from Anktiva sales expected in the coming months as distribution to urologists and other healthcare providers begins.