ImmunityBio Stock Soars on FDA Talks for Anktiva sBLA Resubmission

Core Insights - ImmunityBio's shares increased by 17.4% following a meeting with FDA officials to discuss the regulatory path for Anktiva in treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors [1][6] - The company plans to resubmit its supplemental biologics license application (sBLA) for Anktiva plus Bacillus Calmette-Guérin (BCG) after addressing FDA's requests for additional information [4][10] Company Developments - Anktiva is already approved in the U.S., EU, and UK for treating adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS) [2] - The recent FDA meeting allowed ImmunityBio to present over five years of follow-up data supporting the papillary indication, demonstrating a safety profile consistent with the approved CIS indication [3][5] - The company has completed the requested analyses and plans to submit the sBLA package within a month, without the need for a new clinical study [4][6] Clinical Evidence - The proposed sBLA resubmission is supported by long-term data from the phase II/III QUILT-3.032 study, which showed a 12-month disease-free survival rate of 58.2% in patients with high-grade papillary-only disease [7] - Disease-specific survival reached 96% at 36 months, with progression-free survival at 94.9% at 12 months and 83.1% at 36 months, indicating sustained disease control [8] - Anktiva demonstrated a bladder-sparing benefit, with cystectomy-free survival rates of 92.2% at 12 months and 81.8% at 36 months, allowing over 80% of patients to avoid radical surgery [8][10] Market Context - High-grade papillary NMIBC that does not respond to BCG represents a significant unmet medical need, as current standard treatment involves radical cystectomy, which has considerable morbidity [9] - ImmunityBio aims to provide a bladder-sparing alternative, potentially reshaping the treatment landscape for these patients if Anktiva is approved [10][12]