Anktiva Receives SFDA Conditional Approval For Metastatic NSCLC And NMIBC

The Saudi Food and Drug Authority has issued conditional approval for Anktiva with immunotherapy for adults with metastatic non-small cell lung cancer whose disease has progressed after standard treatment. The decision makes the SFDA the first regulator worldwide to grant conditional approval for Anktiva in this lung cancer indication, which targets patients who have limited remaining therapeutic options and need additional choices.

The SFDA also authorised Anktiva in combination with Bacillus Calmette–Guérin for adults with high-risk, BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ. This bladder cancer approval relies on clinical data showing meaningful tumour responses in patients who had already failed standard BCG therapy, a group that often faces few effective alternatives after recurrence.

Regulators stated that these decisions align with the Health Sector Transformation Program under Saudi Vision 2030, which aims to improve access to modern therapies and raise healthcare quality. By granting conditional approval for a new immunotherapy-based approach, the SFDA highlights its strategy to support evidence-based innovation while requiring further data to secure long-term confirmation of clinical benefit.

Anktiva, or nogapendekin alfa inbakicept, works through stimulation of the interleukin-15 receptor. The medicine activates natural killer cells, CD4+ T cells, CD8+ T cells, and memory T cells. It does this without driving growth of immuno-suppressive regulatory T cells, which can weaken immune responses. This targeted immune activation underpins its use in both lung and bladder cancer.

The SFDA based the metastatic non-small cell lung cancer approval on a single-arm clinical trial. The study enrolled patients whose cancer had progressed despite one or more earlier treatments, including immune checkpoint inhibitors. Investigators observed a potential survival improvement in this heavily pre-treated group. Using these findings, the SFDA granted conditional approval, linked to a requirement for a confirmatory study demonstrating sustained clinical benefit.

For high-risk, BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, regulators relied on a trial where Anktiva was added to Bacillus Calmette–Guérin. The study showed a complete response rate of 62 percent, which served as the primary endpoint. Taken together, the response data led the SFDA to regard Anktiva as an additional option for patients with recurrent disease after standard BCG therapy.

Anktiva SFDA approval, dosing schedules and safety profile

Dosing differs by indication. For metastatic non-small cell lung cancer, Anktiva is given by subcutaneous injection. For non-muscle-invasive bladder cancer, it is administered by intravesical instillation, where the medicine is placed directly into the bladder. These routes are chosen to match disease location and clinical practice patterns in oncology and urology settings.

The SFDA reported frequent adverse events in bladder cancer studies, including raised creatinine levels, painful or difficult urination, visible blood in the urine, and urgent or frequent urination. Other events included urinary tract infections, increased potassium, muscle pain, bone pain, chills, and fever. In lung cancer trials, common events included injection-site redness, pain or itching, along with chills, fatigue, fever, nausea, influenza-like symptoms, and reduced appetite, as shown below.

Overall, the SFDA stated that Anktiva’s approvals followed a full assessment of available evidence on efficacy, safety, and quality. Conditional status for the metastatic non-small cell lung cancer indication depends on results from a future confirmatory trial. These regulatory decisions add a new immunotherapy-based treatment choice for certain lung and bladder cancer patients in Saudi Arabia, with expectations of better disease and survival outcomes where standard therapies have failed.

With inputs from SPA