Muscle Invasive Bladder Cancer with Papillary Disease; PDUFA Date Set for January 6, 2027

Key Points:

• The FDA has accepted ImmunityBio’s supplemental Biologics License Application (sBLA) to expand the ANKTIVA® label to include treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS), assigning a PDUFA target action date of January 6, 2027.
• The sBLA is supported by data from the QUILT 3.032 Phase 2/3 trial showing a 12-month disease-free survival rate of 58.2% in patients with high-grade papillary-only NMIBC, alongside strong secondary endpoints including progression-free survival of 94.9% at 12 months and cystectomy-free survival of 92.2%.
• FDA workshop panelists and the NCCN expert panel have recognized the biological overlap between papillary disease and CIS, supporting the rationale to treat papillary-only disease with therapies approved for CIS, reflecting current real-world clinical practice and reinforcing the need for an approved therapy for papillary disease alone.
• ANKTIVA plus BCG was previously FDA-approved in April 2024 for BCG-unresponsive NMIBC with CIS, and an expanded indication would broaden treatment options for the approximately 85% of NMIBC patients presenting with papillary disease, potentially reducing the need for radical cystectomy.
• ImmunityBio highlights ANKTIVA’s mechanism as an IL-15 receptor agonist that activates NK and CD8+ T cells to restore immune response against cancer, and emphasizes the importance of this chemotherapy-free immunotherapy as a durable, bladder-sparing treatment option for high-risk NMIBC patients.