ImmunityBio's ANKTIVA Wins Global Approvals and Expands Cancer Therapy Trials

ImmunityBio's cancer therapy ANKTIVA has gained approval in 33 countries across four global jurisdictions. The treatment recently secured its first conditional approval from China's State Food and Drug Administration (SFDA) for metastatic non-small cell lung cancer. Meanwhile, the company is pushing ahead with new applications and expanding its production capabilities for next-generation cell therapies.

ANKTIVA has shown strong financial growth, with net product revenue reaching $113 million in 2025—a nearly 700 percent increase from the previous year. The therapy's potential extends beyond lung cancer, as ImmunityBio has submitted a supplemental Biologics License Application (BLA) to the US Food and Drug Administration (FDA). This submission seeks approval for ANKTIVA combined with BCG in patients with BCG-unresponsive non-muscle-invasive bladder cancer.

Recent clinical progress includes the Phase I QUILT-3.076 trial, which confirmed the safety of M-ceNK (memory cytokine-enhanced natural killer) cells when used alongside ANKTIVA. The study involved ten cancer patients who received 23 doses of their processed cells, with no serious adverse events reported. In preclinical tests, combining M-ceNK cells with ANKTIVA led to statistically significant tumor shrinkage in two xenograft models of small-cell lung cancer. The company has also validated a scalable production platform for its NK cell therapies. A single leukapheresis procedure can now generate up to five billion NK cells—enough for eight to ten therapeutic doses in roughly twelve days. Notably, NK cells derived from cancer patients retained cytotoxic activity comparable to those from healthy donors, even against typically NK-resistant tumor cell lines. Neuroendocrine tumors, which often lack MHC class I expression, resist T cell-based immunotherapies but remain vulnerable to NK cell-mediated killing. This vulnerability positions ANKTIVA and similar NK cell therapies as promising alternatives for hard-to-treat cancers.

With approvals expanding and clinical trials advancing, ANKTIVA continues to demonstrate both safety and efficacy. The therapy's scalable production and broad applicability across tumor types suggest growing adoption in oncology treatment. ImmunityBio's ongoing regulatory submissions and revenue growth further signal its commitment to widening access.