ImmunityBio’s Combination Therapy Approved for Bladder Cancer

April 24, 2024
Red FDA approval stamp beside blue and white pills.

⁤The U.S. Food and Drug Administration (FDA) has recently approved ImmunityBio’s combination therapy for vaccine-resistant bladder cancer. As this condition affects 75-85% of bladder cancer patients, finding suitable therapies is urgent. This approval is a exciting turnaround for the company, which previously faced FDA rejection due to deficiencies at its contract manufacturing firms. ⁤⁤The therapy, known as Anktiva, is used alongside the Bacillus Calmette-Guérin (BCG) vaccine, thereby targeting bladder cancer that does not respond to BCG alone. ⁤⁤

⁤Anktiva enhances long-term cancer immunity by stimulating natural killer (NK) cells and T-cells. ⁤⁤In a late-stage study of 83 patients, Anktiva achieved a 71% complete tumor disappearance rate, with a median response duration of 24.1 months. ⁤⁤While this product is set for release in the United States by mid-May 2024, pricing details remain undisclosed. ⁤⁤ImmunityBio’s executive chairman, Patrick Soon-Shiong, emphasized the therapy’s potential for long-term cancer-free survival, aiming to improve cancer care outcomes. ⁤

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[Source: Reuters, April 23, 2024]

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