Saudi SFDA grants world-first approval for Anktiva in lung cancer

SAUDI ARABIA—The Saudi Food and Drug Authority (SFDA) has granted conditional approval for Anktiva (nogapendekin alfa inbakicept) combined with immunotherapy to treat adult patients with metastatic non-small cell lung cancer (NSCLC) who have exhausted standard treatment options.

This marks the first time any regulatory authority worldwide has conditionally approved this medication for NSCLC treatment.

The SFDA had previously approved Anktiva in combination with Bacillus Calmette–Guérin (BCG) for adult patients with high-risk, BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ.

Anktiva operates through a novel mechanism by binding to the interleukin-15 (IL-15) receptor, which triggers the proliferation and activation of natural killer cells, CD4+ cells, CD8+ cells, and memory T cells.

Importantly, this process occurs without promoting the growth of immunosuppressive regulatory T cells.

Lung cancer patients receive Anktiva through subcutaneous injection, while bladder cancer patients receive the treatment via intravesical instillation directly into the bladder.

The SFDA based its approval on a comprehensive evaluation of all available evidence, including efficacy, safety, and quality data that met regulatory requirements.

In NSCLC, a single-arm clinical trial in patients who had failed one or more prior therapies, including immune checkpoint inhibitors, demonstrated potential survival benefits.

However, the SFDA requires a confirmatory trial to prove long-term clinical benefit to maintain this conditional approval status.

In bladder cancer trials, Anktiva achieved a 62% complete response rate, which served as the primary endpoint for approval in this indication.

The SFDA views these collective results as evidence that Anktiva represents a valuable new treatment option for patients who have limited alternatives, potentially improving disease outcomes and survival rates.

Bladder cancer clinical trials reported common adverse events including elevated creatinine levels, painful or difficult urination, blood in urine, and urinary urgency or frequency.

Additional side effects included urinary tract infections, increased potassium levels, muscle and bone pain, chills, and fever.

Lung cancer trial participants most frequently experienced injection-site reactions such as redness, pain, or itching, along with chills, fatigue, fever, nausea, influenza-like symptoms, and appetite loss.

This approval demonstrates the SFDA’s ongoing dedication to innovation and expanding access to advanced treatments, enhancing healthcare quality in alignment with the Health Sector Transformation Program under Saudi Vision 2030.