ImmunityBio Slapped With FDA Refusal To File Letter For Expanded Use Of Its Bladder Cancer Drug

Core Viewpoint - ImmunityBio, Inc. received a Refusal to File (RTF) letter from the FDA for the supplemental biologics license application (sBLA) for ANKTIVA plus BCG in treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease, despite prior unanimous guidance from FDA leadership to submit the application [1][2][3] Group 1: FDA Interaction - The RTF letter was unexpected as the FDA's leadership had previously encouraged the company to submit the sBLA during a January 2025 meeting [2] - The company has requested an urgent meeting with the FDA to address the inconsistencies between the guidance received and the RTF letter [3][6] Group 2: Clinical Trial Data - ANKTIVA was previously approved by the FDA in 2024 for BCG-unresponsive NMIBC with papillary tumors with CIS [3] - Long-term results from the clinical trial (QUILT-3.032) showed a disease-specific overall survival rate of 99% at 12 months and 96% at 36 months for patients with papillary disease without CIS [4][5] Group 3: Market Reaction - Following the news of the RTF letter, ImmunityBio's stock (IBRX) fell by 16.50% to $2.12 in premarket trading [7]