ImmunityBio Bags US FDA Nod For Anktiva to treat Patient with Bladder Cancer

ImmunityBio, Inc, a biotechnology firm, declared that Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) is now approved by the US Food and Drug Administration for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), whether or not papillary tumors are present.

“The US FDA’s approval of Anktiva marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors,” said Patrick Soon-Shiong, executive chairman and global chief scientific and medical officer at ImmunityBio. “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 tumor 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 tumor types, regardless of the site of origin.”

Anktiva, a first-in-class IL-15 agonist immunotherapy for NMIBC, has gained FDA Breakthrough Therapy Designation and approval based on the safety and efficacy of complete responses (CR) and duration of complete response (DOR). This single-arm, multicenter trial included 77 evaluable patients who received Anktiva plus BCG maintenance therapy for up to 37 months. Cystoscopy and urine cytology were used to assess tumor status, and this will be done for up to five years after each patient begins participating in the clincial trial.