Daijiworld Media Network - Riyadh
Riyadh, Jan 17: The Saudi Food and Drug Authority (SFDA) has granted conditional approval for Anktiva, a groundbreaking cancer therapy, for adult patients with advanced non-small cell lung cancer (NSCLC) and high-risk bladder cancer. This makes Saudi Arabia the first nation globally to approve the treatment for NSCLC, offering new hope for patients whose disease has progressed after standard therapies.
What is Anktiva?
Also known as nogapendekin alfa inbakicept, Anktiva is an immunotherapy that empowers the body’s immune system to identify and destroy cancer cells. It selectively activates immune cells that attack tumors while sparing those that suppress immune responses. The method of administration varies by cancer type: for advanced NSCLC, it is given as a subcutaneous injection, while for bladder cancer unresponsive to standard treatments, it is delivered directly into the bladder.
The SFDA’s decision is based on clinical evidence demonstrating Anktiva’s potential benefits for patients with limited treatment options. In NSCLC, trials involving patients whose disease progressed after prior therapies, including immune checkpoint inhibitors, indicated a possible improvement in survival. Conditional approval will require further studies to confirm its long-term benefits. For bladder cancer, clinical trials reported a 62% complete response rate, which formed the basis for regulatory approval.
Common side effects observed in bladder cancer patients included elevated creatinine, painful urination, blood in the urine, urinary frequency or urgency, urinary tract infections, high potassium levels, muscle and bone pain, chills, and fever. In lung cancer trials, patients most commonly experienced injection-site reactions, chills, fatigue, fever, nausea, flu-like symptoms, and reduced appetite.
The approval of Anktiva aligns with the SFDA’s broader efforts to expand access to innovative therapies and enhance healthcare quality under Saudi Arabia’s Health Sector Transformation Program, a cornerstone of Vision 2030. By authorizing this treatment, the country not only offers new hope to patients with advanced cancers but also sets a global precedent in the regulatory approval of next-generation cancer therapies.