Dr. Patrick Soon‑Shiong said Saudi Arabia’s FDA has approved ImmunityBio’s immunotherapy Anktiva for bladder and lung cancer, expanding its indications beyond the limited U.S. approval for a form of non‑muscle‑invasive bladder cancer. Anktiva activates natural killer (NK) cells to target tumors, and ImmunityBio cites decade‑long trials suggesting survival benefits across multiple cancers. Soon‑Shiong, who largely self‑funded development, expressed frustration at the U.S. FDA’s limited approval and said the Saudi decision could influence future U.S. regulatory review.
Saudi FDA Clears Anktiva for Bladder and Lung Cancer; Soon‑Shiong Urges Broader U.S. Approval
Patrick Soon-Shiong’s cancer drug approved by Saudi FDA
Dr. Patrick Soon‑Shiong said he hopes Saudi Arabia’s regulatory approval of his company ImmunityBio’s immunotherapy, Anktiva, for bladder and lung cancers will help persuade U.S. regulators to expand the drug’s indications.
What Is Anktiva?
Anktiva is an immunotherapy developed by ImmunityBio that is designed to activate the patient’s natural killer (NK) cells to identify and destroy cancer cells. ImmunityBio describes Anktiva as the first FDA‑approved therapy that specifically harnesses NK cells to target non‑muscle‑invasive bladder cancer.
Regulatory Status
The drug already holds a limited approval in the United States for a specified form of non‑muscle‑invasive bladder cancer. On Wednesday, Saudi Arabia’s Food and Drug Authority announced it has authorized Anktiva for both bladder and lung cancers — a broader set of indications than the current U.S. approval.
Soon‑Shiong’s Comments and Evidence
Soon‑Shiong, who has largely financed development of the therapy through private funding, said decade‑long trials and multiple studies show survival benefits across a range of tumor types. He told the television program CUOMO that trials indicate benefits in breast, lung, pancreatic cancers and glioblastoma, and described Anktiva as a potential “universal treatment.”
“The money spent to develop this drug over the last decade has been out of my pocket. We’ve not received any government support… The idea was to find a way to cure cancer. This has been a life dream, and we are very close now,” Soon‑Shiong said.
He also expressed frustration with what he described as only a partial approval by the U.S. Food and Drug Administration and suggested the Saudi decision could influence future U.S. regulatory action as additional trials proceed.
Context And Next Steps
ImmunityBio plans to continue clinical work to expand indications. Regulatory decisions will depend on review of trial data by agencies such as the U.S. FDA. As with any emerging cancer therapy, independent peer‑reviewed evidence and regulatory evaluations will determine how widely Anktiva is adopted across tumor types.
About Soon‑Shiong: Dr. Soon‑Shiong is a biotech entrepreneur and investor; he owns The Los Angeles Times and is a part‑owner of the NBA’s Los Angeles Lakers. He has been a major private funder of Anktiva’s development.
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