FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease

Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio

“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”

Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio

“An important first step as we develop Immunotherapy 2.0.”

Sam S. Chang, Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center

“Patients with high-grade papillary disease that no longer responds to BCG remain at meaningful risk for recurrence and progression and historically have had limited nonsurgical treatment options”

Sam S. Chang, Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center

“The availability of an FDA-approved treatment for this population represents an important addition to the treatment landscape, providing appropriate patients with BCG-unresponsive disease another treatment option that may help preserve the bladder.”

Richard Adcock, President and CEO of ImmunityBio

“The expansion of ANKTIVA plus BCG into papillary-only disease broadens the eligible patient population and establishes it as the first FDA-approved therapy for both CIS and papillary-only disease in BCG-unresponsive NMIBC”

Richard Adcock, President and CEO of ImmunityBio

“Building on strong commercial growth since ANKTIVA’s initial approval, we remain focused on helping eligible patients access this therapy and are grateful to the patients, families, investigators, and clinical teams who made this progress possible.”