SFDA approved the registration of Anktiva for selected bladder and lung cancer indications | iPharmaCenter

Saudi Food and Drug Authority (SFDA) has approved the registration of Anktiva (nogapendekin alfa inbakicept) for selected bladder and lung cancer indications, introducing a new immunotherapy option for patients with limited treatment choices.

Under the new authorization, Anktiva may be used for adult patients with metastatic non‑small cell lung cancer whose disease has progressed after standard systemic therapies, in combination with immune checkpoint inhibitors.

SFDA has also cleared Anktiva for adults with high‑risk, non‑muscle invasive bladder cancer that no longer responds to BCG, where it is added to BCG‑based intravesical treatment.

These two indications target populations with significant unmet need, particularly after failure of existing standards of care.

Anktiva is described as an interleukin‑15 receptor agonist that binds to and stimulates IL‑15 receptors, driving activation and proliferation of natural killer cells and CD8 T cells, while limiting the expansion of regulatory T cells that can dampen antitumor immune responses.

This immune‑modulating profile is intended to enhance the body’s ability to recognize and attack tumour cells when used alongside other therapies.

In metastatic lung cancer, Anktiva is administered subcutaneously in combination with checkpoint inhibitors, whereas in high‑risk non‑muscle invasive bladder cancer it is delivered directly into the bladder via intravesical instillation with BCG.

SFDA reports that the approval followed a comprehensive review of efficacy, safety and quality data generated in clinical studies, in line with applicable regulatory standards.

In the BCG‑unresponsive high‑risk non‑muscle invasive bladder cancer setting, a pivotal trial demonstrated a complete response rate of around 60 percent at a prespecified assessment time, which served as the main efficacy endpoint for the regulatory evaluation.

For metastatic non‑small cell lung cancer, the decision was granted on a conditional or accelerated basis, supported by data from patients who had progressed after one or more prior regimens, including checkpoint inhibitors, where early findings suggested a potential improvement in survival outcomes.

SFDA has required confirmatory studies to substantiate long‑term clinical benefit in lung cancer in order to preserve this conditional status.

The safety profile of Anktiva reflects the immune‑activating nature of the therapy and varies by indication. Lung cancer trials frequently reported injection‑site reactions such as redness or pruritus, chills, fatigue, fever, nausea, flu‑like symptoms and decreased appetite.

According to SFDA, the registration of Anktiva is consistent with the authority’s broader strategy to support innovative therapies and expand access to cutting‑edge oncology treatments for patients in the Kingdom. The move aligns with the objectives of the Health Sector Transformation Program under Saudi Vision 2030, which aims to elevate the quality of care and reinforce Saudi Arabia’s regional and international role in pharmaceutical regulation and modern cancer management.