Billionaire Patrick Soon-Shiong wins wider FDA approval for bladder cancer drug

South African-born billionaire Patrick Soon-Shiong's ImmunityBio Inc. won expanded US approval for its bladder cancer drug Anktiva, nearly three months ahead of schedule, opening the treatment to a far larger group of patients.

The US Food and Drug Administration on Wednesday cleared Anktiva, given with the standard tuberculosis-derived vaccine BCG, for adults whose non-muscle-invasive bladder cancer has stopped responding to BCG and who have papillary-only tumors. The drug's original approval in April 2024 covered only patients with carcinoma in situ, a flat, aggressive form of the disease, with or without papillary tumors.

Papillary disease accounts for about 85% of non-muscle-invasive bladder cancer patients, according to ImmunityBio. The company said the decision makes Anktiva the first FDA-approved therapy for both forms of the disease in patients who no longer respond to BCG. The agency's target date for a decision had been Jan. 6, 2027.

"This approval marks an important expansion of ANKTIVA plus BCG for patients with BCG-unresponsive NMIBC and advances our goal of harnessing the patient's own immune system to achieve durable, tumor-free outcomes," Soon-Shiong, ImmunityBio's founder and executive chairman, said in a statement.

A shortcut on evidence

The FDA did not require a new randomized trial. It extended results from the carcinoma in situ group of ImmunityBio's QUILT-3.032 study to papillary disease, saying the two cancers share clinical and non-clinical features. In that group of 77 patients, 62% had a complete response. Among those who responded, 58% maintained their response for at least 12 months and 40% for at least 24 months.

"We listen to patients, clinicians and researchers, and we act when the science supports a new approach," said R. Angelo de Claro, director of the FDA's Oncology Center of Excellence.

The approval closes a long fight with the agency. The FDA refused to accept ImmunityBio's application for the papillary indication in May 2025, having told the company that a randomized trial was needed for that group. ImmunityBio said at the time that the agency had invited the filing. The company resubmitted in March 2026, and the FDA accepted the application for review in May.

Johnson & Johnson, whose rival bladder cancer treatment Inlexzo was approved for carcinoma in situ in September 2025, is running a randomized late-stage trial in papillary disease.

What the stake is worth

ImmunityBio shares were up more than 5% at $10.32 in afternoon trading on Wednesday before closing up 1.1% at $9.91 on the Nasdaq. They gained about 3% more in premarket trading on Thursday.

Soon-Shiong and entities he controls, including Cambridge Equities, NantWorks and Nant Capital, owned about 654.6 million ImmunityBio shares as of July 31, according to a Schedule 13D filing with the US Securities and Exchange Commission in August. That excludes 2.46 million shares he can buy through stock options and 88.4 million shares Nant Capital could receive by converting a promissory note. Including those, the filing puts his beneficial ownership at 64.8%.

At Wednesday's close, the shares he owns outright were worth about $6.49 billion, roughly $72 million more than a day earlier. When the stock traded at $10.32 during the session, the holding was worth about $6.76 billion.

Anktiva generated $94.8 million of net product revenue in the first half of 2026, including $50.7 million in the second quarter, according to the company's quarterly filing. ImmunityBio plans to seek approval to use the drug in patients who have not yet received BCG.

Soon-Shiong, a surgeon born in Port Elizabeth, South Africa, made his fortune selling two drug companies, APP Pharmaceuticals and Abraxis BioScience, in 2008 and 2010. He also owns the Los Angeles Times.