Saudi Arabia become world's first to conditionally approve Anktiva for advanced lung cancer

Dubai: Saudi Arabia became the first country in the world to grant conditional regulatory approval for Anktiva as a treatment for advanced non-small cell lung cancer, according to the Saudi Food and Drug Authority.

The Saudi Food and Drug Authority has granted conditional approval for Anktiva (nogapendekin alfa inbakicept) to be used alongside immunotherapy in adults with metastatic non-small cell lung cancer whose disease has progressed despite prior treatment. It is the first regulatory authority worldwide to approve the drug for this indication.

In a parallel decision, the authority also approved Anktiva in combination with Bacillus Calmette-Guérin (BCG) for adults with high-risk, BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, a group of patients with limited remaining options.

Anktiva works through a novel mechanism that targets the interleukin-15 (IL-15) receptor, stimulating the body’s immune defences by activating natural killer cells and key T-cell populations involved in fighting cancer, while avoiding the expansion of immune-suppressive regulatory T cells.

For lung cancer patients, the drug is administered by subcutaneous injection. In bladder cancer, it is delivered directly into the bladder, allowing treatment to be concentrated at the disease site.

The conditional approval for lung cancer was based on results from a single-arm clinical study involving patients who had failed one or more previous treatments, including immune checkpoint inhibitors.

The trial suggested a potential survival benefit, prompting regulators to allow the drug’s use while requiring a confirmatory study to verify long-term clinical benefit.

In bladder cancer, clinical trials showed a complete response rate of 62 per cent, with approval granted on the basis of this primary endpoint. Regulators said the results supported Anktiva as a meaningful new option for patients facing disease progression or radical surgery.

According to the SFDA, the most common side effects in bladder cancer studies included painful or difficult urination, blood in the urine, urinary urgency, elevated creatinine levels and urinary tract infections. Other reported effects included fever, chills, muscle and bone pain, and increased potassium levels.

In lung cancer trials, patients most frequently experienced injection-site reactions, fatigue, fever, nausea, chills, flu-like symptoms and reduced appetite.