ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease; PDUFA Date Set for January 6, 2027 - Seite 2

The FDA workshop meeting goals included the issues directly pertinent to sBLA submission currently under review and, as the Agency stated, the focus of the sBLA review as follows:

“Discuss the similarities and differences between the two types of histology (papillary and CIS) observed in NMIBC and implications for the demonstration of efficacy in clinical trials.”

“Patients with BCG-unresponsive NMIBC with papillary disease are faced with the option of a total radical cystectomy and continue to face limited treatment options with no FDA approved therapy to date that strives to preserve the bladder, while reducing the risk of disease progression to muscle-invasive cancer,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “The FDA’s acceptance of this supplemental application for review represents an important step toward potentially expanding access to ANKTIVA plus BCG for patients with high-grade BCG unresponsive NMIBC. We were encouraged by the scientific discussion at the recent FDA workshop regarding the biological overlap between CIS and papillary disease and the current real-world treatment approaches for these patients. We look forward to continuing to work with the Agency during its review of the application.”

Dr. Soon-Shiong who attended the FDA workshop, further stated, “The feedback from the thought leaders at the FDA workshop meeting relating to the real-world clinical treatment of patients with papillary disease alone was significantly important in informing the Agency of the clinical and scientific views of clinicians treating patients with high-grade non-muscle invasive bladder cancer. Of significance was the statements by the panelists at the FDA workshop, that when patients with this indication of papillary disease alone are identified, the conclusion was that CIS may indeed exist but not identified and furthermore the identification of CIS was irrelevant in their treatment decisions. The panelists stated that in this instance, the treatment for these patients in the real-world was to offer therapies that are already approved by the FDA for BCG unresponsive NMIBC with CIS and papillary disease, emphasizing the real-world need for an approved therapy for patients with papillary disease alone. I was grateful for these insights and the consistency of these statements with the recent designation by the expert panel at NCCN to provide Category 2A inclusion as part of the guidelines for practicing physicians managing patients with BCG unresponsive NMIBC papillary disease alone,” he said.

Schreibe Deinen Kommentar