Strong Clinical Data Driving Progress
ImmunityBio, Inc. has announced a major milestone in the treatment of bladder cancer, as its innovative therapy, ANKTIVA, made significant strides in gaining FDA approval for expanded use. With long-term data indicating exceptional survival rates—approximately 96% bladder cancer-specific survival after three years—the therapy sets a promising path for patients with BCG-unresponsive papillary non-muscle invasive bladder cancer.
FDA’s Promising Recommendations
The U.S. FDA held a productive Type B End-of-Phase meeting with ImmunityBio to review its supplemental Biologics License Application. Instead of requesting new clinical trials, the agency asked for supplemental information to support the resubmission, expediting the regulatory process. ImmunityBio has assured a response to these requests within 30 days.
Long-Term Patient Benefits
Published in The Journal of Urology, ANKTIVA’s long-term results show remarkable outcomes. Over 80% of patients in the study achieved bladder preservation three years post-treatment. The FDA had already granted approval for ANKTIVA in April 2024 for use in carcinoma in situ, significantly enhancing its market potential and offering hope to patients with limited treatment options.
Expanding Global Reach
Beyond the United States, ANKTIVA has gained conditional regulatory approvals and is entering markets in the United Kingdom, European Union, and Saudi Arabia. This global expansion underscores the therapy’s disruptive potential in treating bladder cancer worldwide.
Wall Street Optimism
Following this FDA update, ImmunityBio’s stock surged by 19.8% in premarket trading. Analysts, including Piper Sandler’s Edward Tenthoff, have raised ImmunityBio’s price target, citing increasing confidence in the company’s regulatory trajectory. With shares more than doubling recently, experts view this momentum as a positive indicator of the therapy’s financial and clinical promise.
Spotlight on ImmunityBio
For individuals interested in tracking biotech advancements, ImmunityBio is a key player in immunotherapy. As innovation continues in cancer treatment, a focus on therapies such as ANKTIVA could reshape patient outcomes.
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