Saudi Arabia First to Approve Anktiva for Advanced Lung and Bladder Cancer
January 17, 2026
The Saudi Food and Drug Authority (SFDA) has given conditional approval to Anktiva, a new cancer treatment for adults with advanced lung and bladder cancers. Saudi Arabia is now the first country in the world to approve this therapy for non-small cell lung cancer (NSCLC). Anktiva, also called nogapendekin alfa inbakicept, activates the immune system to attack cancer cells. It boosts immune cells that kill tumors while avoiding those that block the immune response.
Anktiva is given in different ways based on cancer type. For advanced NSCLC, it is injected under the skin. For high-risk bladder cancer not responding to usual treatments, the drug is delivered directly into the bladder.
The SFDA's decision is backed by clinical studies showing benefits for patients with few options. In NSCLC trials, patients who had disease progression after treatments, including immune checkpoint inhibitors, showed possible survival improvement. Approval is conditional pending more studies to confirm lasting benefits.
In bladder cancer trials, 62% of patients saw a complete response. Side effects in bladder cancer patients included higher creatinine levels, painful or frequent urination, blood in urine, urinary infections, raised potassium, muscle and bone pain, chills, and fever. Lung cancer patients mainly experienced injection-site redness, pain or itching, chills, fatigue, fever, nausea, flu-like symptoms, and loss of appetite.
The SFDA's approval supports its goal to expand access to advanced treatments and improve healthcare quality, part of Saudi Vision 2030’s Health Sector Transformation Program. By approving Anktiva for NSCLC and bladder cancer, Saudi Arabia offers new hope to patients with serious cancers and leads the world in regulatory progress for innovative therapies.
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Tags:
Saudi Food And Drug Authority
Anktiva
Lung Cancer
Bladder Cancer
Cancer Therapy
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