ImmunityBio's ANKTIVA Gains Global Approval as Cancer Immunotherapy Advances
ImmunityBio has made significant strides in cancer treatment with two key developments. The company's therapy, ANKTIVA, has now gained approval in 33 countries, including the US, UK, and EU. At the same time, its new production platform for natural killer (NK) cell therapies has shown promising results in both safety and scalability.
ANKTIVA, a cancer immunotherapy, received its first global conditional approval from China's SFDA for metastatic non-small cell lung cancer. Since then, regulatory bodies in the United States (April 2024), the United Kingdom (July 2025), Saudi Arabia (January 2026), and the European Union (February 2026) have also granted approval. By 2025, the drug generated $113 million in net revenue—a nearly 700 percent increase from the previous year.
In parallel, ImmunityBio completed the Phase I QUILT-3.076 trial, testing M-ceNK cells combined with ANKTIVA in patients with recurrent or refractory tumors. The trial involved 74 participants and reported no serious adverse events. Preclinical studies also showed that this combination significantly reduced tumor volume in small-cell lung cancer models.
The company has also advanced its NK cell production technology. A single leukapheresis procedure can now yield up to five billion NK cells—enough for eight to ten therapeutic doses in about twelve days. These cells, even when derived from cancer patients, demonstrated cytotoxic activity comparable to those from healthy donors. This is particularly relevant for neuroendocrine tumors, 62 percent of which lack MHC class I expression, making them resistant to T cell therapies but vulnerable to NK cell-mediated killing.
Recently, ImmunityBio submitted a supplemental Biologics License Application (BLA) to the FDA. The application seeks approval for ANKTIVA combined with BCG in treating BCG-unresponsive non-muscle-invasive bladder cancer.
ANKTIVA is now approved across 33 countries, expanding treatment options for multiple cancer types. The company's scalable NK cell production platform, validated for safety and efficacy, could further enhance cancer immunotherapy. With ongoing regulatory submissions and strong revenue growth, ImmunityBio continues to push forward in oncology innovation.
