Last mentioned: Mar 25, 2026
Expected Regional Launch
Anticipated availability of ANKTIVA in Macau oncology centers.
Macau SAR Approval
Macau Health Bureau grants regulatory clearance for ANKTIVA.
Regulatory Warning
FDA flags misleading claims made by Patrick Soon-Shiong regarding off-label uses of Anktiva.
U.S. Commercial Launch
ImmunityBio begins commercial distribution of ANKTIVA in the U.S.
FDA Approval
Anktiva is approved for BCG-unresponsive NMIBC in combination with BCG.
U.S. FDA Approval
ANKTIVA receives first-ever approval for NMIBC in the United States.
Initial Rejection
FDA issues a Complete Response Letter (CRL) for Anktiva due to manufacturing deficiencies.
ImmunityBio Inc. has received regulatory approval for its flagship immunotherapy, ANKTIVA, in the Macau Special Administrative Region of China. This milestone marks the first international expansion for the IL-15 superagonist following its 2024 U.S. FDA approval, positioning the company to tap into the significant oncology market in the Greater Bay Area.
The FDA has issued a formal warning to Dr. Patrick Soon-Shiong, the billionaire founder of ImmunityBio, regarding misleading statements made about the company’s bladder cancer therapy, Anktiva. The regulator flagged claims made during a podcast that suggested the drug could treat a broader range of cancers than its current approval allows.
ImmunityBio (IBRX) shares rallied following the European Commission's marketing authorization of ANKTIVA for BCG-unresponsive non-muscle invasive bladder cancer. This milestone marks the first international expansion for the IL-15 superagonist, significantly broadening its global commercial reach.