- ImmunityBio Executive Chairman Patrick Soon-Shiong criticized the FDA for applying tougher approval standards to Anktiva than to Merck’s Keytruda.
- He said regulators allowed Keytruda to expand across cancers using single-arm trials while requiring Anktiva to run randomized trials in every tumor type.
- Soon-Shiong noted that more than 13,000 patients are seeking access outside the label.
ImmunityBio’s executive chairman, Patrick Soon-Shiong, took direct aim at the FDA this weekend, accusing regulators of fast-tracking Merck’s blockbuster cancer drug Keytruda while keeping Anktiva boxed into a single bladder cancer approval.
In a recent interview on The Roger Stone Show, Soon-Shiong said patients are being caught in a regulatory bottleneck despite what he described as life-saving potential from Anktiva.
FDA Approval Standards Under Fire
Soon-Shiong said the regulatory pathway applied to Anktiva contrasts sharply with how Keytruda was approved and expanded.
“For Anktiva, the number one ranked drug, they are suggesting I do randomized trials in every tumor type, which will take five lifetimes,” he said. “I’m going to give them as confirmation trials, but in the meantime, Americans are dying.” He added that Keytruda, which he called the “number two ranked” immune therapy historically, was allowed to move forward based on single-arm trials across multiple cancers.
Anktiva is currently approved in the U.S. only in combination with Bacillus Calmette-Guerin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. However, Soon-Shiong said patients outside that label cannot access it.
“We now have over 13,000 Americans begging for the use of this drug, and they’re not allowed to get it unless they have this subset of bladder cancer,” he said. “It is an asynchronous mechanism of approval.” He argued that Anktiva addresses a fundamental gap in cancer immunotherapy by stimulating natural killer cells and T cells, rather than merely releasing immune “brakes.”
“The irony is the world spent the last decade developing the number two agent,” he said, referring to checkpoint inhibitors like Keytruda, “while the number one agent was left on the shelf because nobody could develop it.”
Anktiva Pushes Toward Wider Approval
In December 2025, the European Medicines Agency recommended conditional marketing authorization for Anktiva in combination with BCG for the same bladder cancer indication. That recommendation is now under review by the European Commission for final approval. Last month, Saudi health regulators also approved Anktiva, used with standard bladder cancer therapy.
Earlier this month, the company launched a mid-stage study evaluating an off-the-shelf CD19 CAR-NK cell therapy in combination with Anktiva and Rituximab in patients with indolent B-cell non-Hodgkin lymphoma, including Waldenström’s Macroglobulinemia, without the need for chemotherapy.
The study builds on prior data showing durable responses with CD19 CAR-NK therapy and Rituximab alone, and will assess whether adding Anktiva can further enhance and prolong anti-tumor activity.
ImmunityBio also plans to resubmit an FDA application seeking approval for Anktiva in BCG-unresponsive bladder cancer with papillary tumors after the agency previously issued a refuse-to-file letter.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment for IBRX was ‘bearish’ amid ‘low’ message volume.
One user said, “they are getting into the future vaccine biotech pathway that does not cause cancer. ..priceless.”
Another user said, “I'm expecting good news this week, and every week after.”
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