FDA Provides Path Forward For ImmunityBio’s ANKTIVA In BCG-Unresponsive Bladder Cancer

ImmunityBio, Inc. announced that it has completed a Type B End-of-Phase meeting with the U.S. Food and Drug Administration to discuss its supplemental Biologics License Application for ANKTIVA® in combination with BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors. The meeting focused on the clinical progress and regulatory pathway for expanding the approved use of ANKTIVA in this patient population.

During the discussion, ImmunityBio presented more than five years of follow-up data from its papillary disease program, demonstrating strong long-term outcomes. Key highlights included approximately 96% disease-specific survival at 36 months, with median survival not yet reached after five years, as well as high rates of cystectomy avoidance, 92% at one year and 82% at three years. The safety profile was consistent with ANKTIVA’s currently approved indication in carcinoma in situ, with or without papillary tumors.

“We appreciate the FDA’s collaboration throughout this process and remain fully committed to delivering this much-needed therapy to patients who currently have no approved alternatives when standard of care fails,” said Richard Adcock, President and CEO of ImmunityBio. “We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days for the Agency’s review.”

The meeting also included perspectives from leading urologists, who shared real-world treatment practices for patients with BCG-unresponsive disease, a setting in which radical cystectomy is often the remaining treatment option. These clinical insights reinforced the unmet need for durable, bladder-sparing therapies in this high-risk population.

Following the meeting, the FDA recommended that ImmunityBio submit additional information to support potential resubmission of the sBLA, which was initially filed in 2025. The Company has compiled the requested materials and plans to submit them within 30 days. Importantly, the additional information does not require initiating a new clinical trial, reflecting a collaborative, clearly defined regulatory path forward for ANKTIVA in papillary NMIBC.