If you missed NewsNation’s “Killing Cancer: The Power Within” special report, you can watch it here.

(NewsNation) — Can cancer be killed? Billionaire Dr. Patrick Soon-Shiong, who also owns the LA Times and co-owns the Los Angeles Lakers, says yes.

Soon-Shiong’s ImmunityBio developed Anktiva, a treatment that harnesses the body’s immune system to destroy cancer tumors, potentially making chemotherapy obsolete. He claims it has miraculous results, but he’s unable to get it through regulatory hurdles.

Read this article to learn more about Anktiva from Soon-Shiong himself. You can also read more of his articles here or follow his X account @DrPatSoonShiong.

What is Anktiva?

Anktiva, according to ImmunityBio, is the first FDA-approved immunotherapy that activates what’s called a natural killer cell to target and kill non-muscle-invasive bladder cancer cells.

Anktiva is combined with BCG, or Bacillus Calmette-Guérin, an immunotherapy drug delivered to the bladder through a catheter. It’s intended for people who have non-muscle invasive bladder cancer, or NMIBC, and for whom BCG alone was not effective.

At present, the drug has only been approved by the FDA for this specific type of bladder cancer.

How does Anktiva work?

Anktiva is not a chemotherapy or gene therapy. It’s an immunotherapy that activates the body’s cancer-fighting cells.

According to Soon-Shiong, natural killer cells in the human body have a receptor “that’s looking for a protein that your body makes called interleukin 15.”

“Anktiva is that IL-15,” Soon-Shiong explains. “It is the switch that actually binds to the NK cell and activates and proliferates them.”

In other words, when the natural killer cell is treated with IL-15, the cell becomes stronger, more durable and multiplies faster, making the body better equipped to take on and kill the cancer cells.

Is Anktiva FDA-approved?

The Food and Drug Administration approved Anktiva on April 22, 2024, specifically to treat adult patients with stage zero BCG-unresponsive NMIBC, with carcinoma in situ, or CIS, with or without papillary tumors.

In May, the FDA refused to expand Anktiva’s use to patients with BCG-unresponsive non-muscle NMIBC who have papillary disease only.

What do clinical trials reveal about the efficacy of Anktiva?

The drug was tested in a clinical trial of 77 patients who had bladder cancer but were unresponsive to BCG treatment alone. The patients’ cancer was at stage zero, the earliest form of cancer.

Patients received Anktiva via a catheter, followed by maintenance therapy for up to 37 months, the maximum duration of the treatment.

The trials found a complete response rate of 62%. Complete response, or CR, indicates the complete disappearance of all detectable signs of cancer after treatment.

Of those patients whose cancer signs disappeared, 58% did not show cancer signs for 12 months or longer, and 40% did not show cancer signs for 24 months or longer.

Soon-Shiong said nearly 1,000 patients have been treated successfully with Anktiva, many after standard treatments failed. He reports patients with bladder cancer alive 10 years later, metastatic pancreatic cancer patients surviving six years and complete remissions across multiple cancer types.

However, FDA regulations require additional clinical trials before the drug can be approved for widespread use across different cancer types.

What are the side effects of Anktiva?

Side effects of Anktiva can include:

• Increased creatinine, a waste from protein and muscle breakdown
• Pain, burning or discomfort during urination
• Blood in urine
• Increased urge to urinate
• Urinary urgency
• Urinary tract infection
• Increased potassium
• Musculoskeletal pain
• Chills
• Fever

What do critics say about Anktiva?

ImmunityBio had hoped to expand Anktiva for use on patients with BCG-unresponsive non-muscle NMIBC who have papillary disease only, but the FDA denied the supplemental application.

In response, ImmunityBio argued that the FDA has already “approved a product based on that very same study in essentially the same indication and population,” said Dr. Rachel Sherman, former FDA principal deputy commissioner, in an ImmunityBio news release.

“… it is incomprehensible to me that the FDA refuses to file a supplemental BLA, stating the study is not sufficient to support a regulatory review, when it has already approved a product based on that very same study in essentially the same indication and population,” Sherman said.

In September, the FDA sent a letter to BioScience, a subsidiary of ImmunityBio, regarding misleading promotional claims for Anktiva on its health care provider website.

The site claimed that after 36 months, 84% of respondents avoided bladder removal surgery and that there was a 99% survival rate, but the FDA said these claims couldn’t be proven in the clinical trial, which lacked a control group.

Soon-Shiong faces criticism from some in the medical establishment who question whether his marketing outpaces his scientific proof. 

In the late 1990s, Soon-Shiong’s diabetes research program collapsed after discovering a potential virus contamination risk. Angry investors sued him, and he was forced to abandon all diabetes work for five years as part of a settlement, though he maintains he did nothing wrong and was simply being cautious about patient safety.

How do Dr. Soon-Shiong and other cancer specialists respond to criticism of Anktiva?

Soon-Shiong continues to lobby President Donald Trump’s administration to support expanding Anktiva’s use for other types of cancer.

In a meeting with Trump and Saudi Arabia’s Crown Prince Mohammed bin Salman, Soon-Shiong said curing cancer “is the best foreign policy we could have, because that is for humanity rather than left, right.”

In response to criticism that he’s catering to MAGA to further his own business interests and is motivated by money, Soon-Shiong stated, “I’m using my own resources and my own effort and my own time to actually figure out how we can actually improve cancer care for all of humanity.”

“It doesn’t matter in terms of the money, in terms of billions. But what does matter is no money, no mission,” he added.

Dr. Steven Finklestein, the national director of radiation oncology for U.S. Urology Partners, who was featured in NewsNation’s special “Killing Cancer: The Power Within,” said the entire field is desperate for a change.

“There’s so many patients with cancers, afflicted with cancer, that we could do so much more for,” he said.

“It’s so important to figure out if it works, to get it to a place where everyone gets access,” Finkelstein added.

Dr. Simon Khagi, the medical director of neuro-oncology at Hoag Family Cancer Institute, expressed support for an expedited approval process, stating, “I think the rules need to be maybe a little different, maybe a little bit more relaxed to allow for things and development to move faster.”