FDA Approves ImmunityBio's Bladder Cancer Drug After Second Review

After initially rejecting ImmunityBio’s Anktiva due to quality issues at a contract manufacturing plant, the FDA has now approved the drug for the treatment of bladder cancer. Anktiva (nogapendekin alfa inbakicep, or N-803) is designed for use in combination with the BCG vaccine in patients with non-muscle invasive bladder cancer (NMIBC) who have not responded to the BCG vaccine alone.

Anktiva operates as a first-in-class IL-15 receptor agonist, activating natural killer (NK) and T-cell cells to attack tumors, and memory T cells to prolong the immune response. It can be used as maintenance therapy with BCG for up to 37 months in adults with NMIBC.

In the QUILT 3.032 trial, the combination of Anktiva and BCG achieved a 71% complete response rate, a median duration of response of nearly 27 months, and a 90% reduction in the need for bladder removal surgery. This approval provides a new treatment option for BCG-unresponsive NMIBC patients, alongside existing treatments like MSD/Merck & Co’s Keytruda and Ferring Pharma’s Adstiladrin.

ImmunityBio plans to launch Anktiva in the US market next month, although pricing details have not yet been disclosed. This approval is a significant milestone for ImmunityBio, offering hope for patients with limited treatment options and potentially reducing the need for bladder removal surgeries.