FDA approves ImmunityBio’s Anktiva bladder cancer treatment
Betsy Goodfellow | April 23, 2024 | News story | Medical Communications | Anktiva, FDA, ImmunityBio, Oncology, bladder cancer
ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.
The drug gained Breakthrough Therapy Designation and approval from the FDA following the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR). A trial assessed the drug in 77 evaluable patients who received Anktiva and BCG maintenance therapy for up to 37 months. The CR rate in these patients was 62% with DOR analysis ongoing.
Patrick Soon-Shiong MD, executive chairman and global chief scientific and medical officer at ImmunityBio, commented: “The FDA’s approval of Anktiva marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors. Anktiva not only proliferates and activates the patient’s own NK cells and CD8+ killer T-cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T-cells. This novel mechanism of action, which mimics the biology of the dendritic cell, begins the evolution of immunotherapy beyond T-cells alone. The combination of the proliferation of key cancer-killing immune cells, together with the activation of T-cells with memory, results in durable complete responses. The ‘triangle offense’ of tumour cell killing by the body’s immune system with long-term memory is the foundation of our efforts to develop a therapeutic cancer vaccine across multiple tumour types, regardless of the site of origin.”
Betsy Goodfellow
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