ImmunityBio's ANKTIVA and NK cell therapies redefine cancer treatment in 2025

ImmunityBio has made significant strides in cancer treatment with its latest therapies. The company recently submitted a supplemental Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ANKTIVA, used alongside BCG, in patients with BCG-unresponsive non-muscle-invasive bladder cancer. This move follows a surge in global approvals and revenue for the drug in 2025.

ANKTIVA has now secured full approval in four key jurisdictions—the USA, UK, Saudi Arabia, and the EU—covering a total of 33 countries. While the EU approval remains conditional, China's State Food and Drug Administration (SFDA) granted its first global conditional approval for the treatment of metastatic non-small cell lung cancer. The drug's financial success is equally notable, with net product revenue reaching $113 million in 2025, marking a nearly 700 percent increase from the previous year.

Beyond ANKTIVA, ImmunityBio has advanced its next-generation natural killer (NK) cell therapies. The company validated a scalable production platform capable of generating up to five billion NK cells from a single leukapheresis procedure—enough for eight to ten therapeutic doses in about twelve days. This breakthrough supports the development of M-ceNK, a modified NK cell therapy tested in the Phase I QUILT-3.076 trial. The trial confirmed its safety, with no serious adverse events reported across 23 doses given to ten patients with recurrent or refractory tumours. The therapy's potential is further highlighted by its effectiveness against tumours lacking MHC class I expression, which affects 62 percent of neuroendocrine tumours. These tumours resist T cell-based immunotherapies but remain vulnerable to NK cell-mediated killing. In preclinical studies, NK cells derived from cancer patients showed cytotoxic activity comparable to those from healthy donors, even against NK-resistant cell lines. When combined with ANKTIVA, M-ceNK cells achieved statistically significant reductions in tumour volume in two xenograft models of small-cell lung cancer.

ImmunityBio's progress reflects both regulatory success and scientific validation. ANKTIVA's expanding approvals and revenue growth coincide with promising results from its NK cell therapies. The company's scalable production platform and positive trial outcomes position it for further advancements in cancer treatment.