FDA Sets New Review Date for Bladder Cancer Immunotherapy


N-803 — with the brand name Anktiva — plus the Bacillus Calmette-Guérin vaccine is being reviewed by the FDA to treat non-muscle-invasive bladder cancer. The goal date is April 23, 2023.

The FDA has accepted the resubmitted biologics license application (BLA) for ImmunityBio’s N-803 in combination with Bacillus Calmette-Guérin (BCG) vaccine, and set a Prescription Drug User Fee Act target action date of April 23, 2023. The company is seeking approval for N-803, an antibody cytokine fusion protein with the brand name of Anktiva, to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ.

In 2023, the American Cancer Society estimates there will about 82,290 new cases of bladder cancer and 16,710 deaths. Bladder cancer occurs mostly in older people. About 70% to 75% of bladder cancers are non-muscle invasive bladder cancer. The BCG vaccine is the current standard of care in this cancer.

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer and T cells. N-803, an IL-15 superagonist, has a unique mechanism of action that leads to the proliferation of natural killer and T cells. This provides a boost to the immunological response generated by BCG.

In May 2023, the FDA had issued a complete response letter for ImmunityBio’s original BLA. Company officials said the resubmission addresses the agency’s concerns. The company provided regulators with an update on the duration of complete response in BCG-unresponsive patients from the QUILT-3.032 study that demonstrated a prolonged duration of remission. In the responding BCG-unresponsive patients updated efficacy data demonstrated a probability of avoiding a cystectomy at more than 24 months of more than 90%.

ImmunityBio also provided an update on the long-term follow-up from QUILT-205 study in BCG naïve patients demonstrating a prolonged duration of complete remission in all of the six patients available for follow-up with a median survival of 8.8 years.

N-803 is also being studied in combination with a PD-L1 to treat advanced metastatic pancreatic cancer; after ipilimumab to treat head and neck cancer; and in combination with ImmunityBio’s Tri-Ad5 cancer vaccine to reduce the risk of developing colorectal and other cancers in patients with hereditary Lynch syndrome.

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