Anktiva Receives SFDA Conditional Approval For Metastatic NSCLC And High-Risk NMIBC

The Saudi Food and Drug Authority (SFDA) has granted conditional approval for Anktiva (nogapendekin alfa inbakicept) with immunotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) whose disease progresses after standard treatment. The SFDA also authorised Anktiva with Bacillus Calmette–Guérin (BCG) for high-risk, BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), and is the first regulator worldwide to approve Anktiva for NSCLC.

The SFDA based its decisions on a full review of clinical data covering efficacy, safety, and quality, in line with regulatory standards. Anktiva is viewed as an additional choice for patients who have limited options and serious disease, with the aim of improving both cancer control and survival outcomes in Saudi Arabia.

For NSCLC, the conditional approval followed a single-arm clinical trial involving patients whose cancer did not respond to one or more earlier therapies, including immune checkpoint inhibitors. The study suggested a possible survival benefit. On this basis, the SFDA allowed conditional use of Anktiva, administered as a subcutaneous injection for these lung cancer patients.

The SFDA decision for NMIBC was supported by trial findings showing a 62% complete response rate in adults with high-risk, BCG-unresponsive disease and CIS. The complete response rate served as the primary endpoint. For this bladder cancer indication, Anktiva is given by intravesical instillation directly into the bladder, together with BCG.

Anktiva acts as an interleukin-15 (IL-15) receptor agonist, binding to the IL-15 receptor and triggering the proliferation and activation of natural killer cells, CD4+ T cells, CD8+ T cells, and memory T cells. At the same time, it does not stimulate growth of immuno-suppressive regulatory T (Treg) cells, which can limit immune responses.

Anktiva NSCLC NMIBC safety profile and adverse events

In bladder cancer trials, the SFDA reported that common adverse events included elevated creatinine levels, painful or difficult urination, visible blood in the urine, and frequent or urgent need to pass urine. Other side effects observed were urinary tract infections, increased potassium, muscle and bone pain, chills, and fever among participants.

In lung cancer studies, the most frequent adverse events involved injection-site reactions such as redness, pain, or itching. Patients also reported chills, fatigue, fever, nausea, influenza-like symptoms, and reduced appetite. These safety findings were considered during the SFDA’s assessment of the benefit–risk balance for Anktiva in metastatic NSCLC.

The SFDA requires a confirmatory trial to show long-term clinical benefit in NSCLC to keep the conditional approval in place. The authority states that these decisions align with efforts to support advanced treatment options and improve healthcare quality under the Health Sector Transformation Program, one of the central initiatives within Saudi Vision 2030.

With inputs from SPA