ImmunityBio Chairman Slams FDA Over Double Standards in Cancer Treatment Approval

ImmunityBio's Executive Chairman Patrick Soon-Shiong has publicly criticized the FDA for what he sees as double standards in approval processes. The company is pushing for broader global access to its cancer treatment, Anktiva, which is currently only approved in combination with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer.

Soon-Shiong argued that the FDA applied tougher approval standards to Anktiva compared to Merck's Keytruda. He noted that while Keytruda was allowed to expand across multiple cancers using single-arm trials, Anktiva requires randomized trials in every tumor type. This would take five lifetimes, he claimed.

According to Soon-Shiong, over 13,000 patients are seeking access outside the approved label for Anktiva, which he described as a life-saving treatment. He criticized the regulatory bottleneck and said that Americans are dying while waiting for approval. The executive chairman also pointed out that Keytruda was developed in the last decade using single-arm trials.