ANKTIVA wins global approval in 33 countries for advanced cancer treatments

The cancer treatment ANKTIVA has now gained approval in 33 countries across four major regions. Regulators in the US, UK, EU, Saudi Arabia, and China have greenlit its use for specific cancers, including bladder cancer and metastatic lung cancer. The drug's rapid expansion follows strong clinical results and a surge in revenue last year.

ANKTIVA first received conditional approval in China for metastatic non-small cell lung cancer (NSCLC). Shortly after, the US Food and Drug Administration (FDA) authorised it in April 2024 for BCG-unresponsive bladder cancer with carcinoma in situ (CIS), when combined with BCG. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) followed in July 2025, while the European Union—covering 27 states plus Iceland, Norway, and Liechtenstein—granted approval in February 2026. Saudi Arabia's SFDA also approved it for bladder cancer and, uniquely, as a first-in-class treatment for metastatic NSCLC alongside checkpoint inhibitors.

Clinical trials have reinforced its safety and effectiveness. The Phase I QUILT-3.076 study found no serious side effects in ten patients given 23 doses of processed NK cells after enrichment. These NK cells, even when sourced from cancer patients, showed cytotoxic activity comparable to those from healthy donors—including against typically resistant tumor lines. When combined with ANKTIVA, they also significantly reduced tumor volume in small-cell lung cancer models. Behind the scenes, ImmunityBio has refined its production process. A single leukapheresis procedure now yields up to five billion NK cells—enough for eight to ten doses in about twelve days. This scalable platform supports the company's next-generation NK cell therapies. Meanwhile, ANKTIVA's commercial success grew in 2025, with net revenue hitting $113 million, a 700% increase from the prior year. The drug's potential extends to neuroendocrine tumors, 62% of which lack MHC class I expression. This makes them resistant to T cell therapies but vulnerable to NK cell-based treatments like ANKTIVA. ImmunityBio has also submitted a supplemental Biologics License Application (BLA) to the FDA for its use with BCG in bladder cancer.

ANKTIVA is now approved in 33 countries, with regulators endorsing its use in bladder cancer and metastatic lung cancer. The drug's strong clinical performance, scalable production, and rising revenue highlight its growing role in oncology. Further FDA reviews could expand its applications in the near future.