Saudi Arabia Records Treatment for Bladder and Lung Cancer Patients

SadaNews - The Saudi Food and Drug Authority has approved, under conditional approval and as the first global regulatory body, the use of the product "Anketiva" (Njugabendikine Alpha Inbacesept) for treating adult patients with metastatic non-small cell lung cancer (NSCLC) as an adjunct treatment to immunotherapies, specifically in cases of disease progression and after standard treatment failure.

The authority also approved the use of the same product for adult patients with high-risk and non-muscle invasive bladder cancer (NMIBC), as an adjunct treatment to the standard therapy (BCG) for those who did not respond to it.

The authority clarified that this product works innovatively by binding and stimulating "Interleukin-15" receptors; this leads to the activation and proliferation of natural killer cells, and T-cells to selectively stimulate the immune system, with limited proliferation of regulatory T-cells that suppress immune response.

Additionally, the product is administered to lung cancer patients through subcutaneous injection, while it is given to bladder cancer patients via direct injection into the affected bladder.

The "Food and Drug Authority" stated that the registration of the product came based on a comprehensive evaluation of all evidence including its efficacy, safety, and quality, according to established regulatory requirements, noting that the results of the clinical study on patients with non-muscle invasive bladder cancer showed a complete response rate of 62 percent, which was adopted as the study's primary endpoint.

It clarified that conditional approval for the medical claim related to lung cancer was based on a clinical study conducted on patients who had not previously responded to one or more treatments, including immune barriers, and initial indicators suggested a potential improvement in survival rates. The authority also stipulated that to maintain the conditional approval status, confirmatory studies must be conducted to demonstrate the long-term clinical benefit.

Based on these results, the authority sees that the product provides a new therapeutic option for patients with limited treatment alternatives; contributing to enhancing opportunities for disease control and improving survival rates.

It mentioned that the most common side effects observed during clinical studies in bladder cancer included: increased creatinine, dysuria, hematuria, frequent urination, as well as urinary tract infections, increased potassium, muscle and bone pain, chills, and fever.

As for clinical studies related to lung cancer, they showed that the most common side effects included: injection site reactions such as redness or itching, along with chills, fatigue, fever, nausea, flu-like symptoms, and loss of appetite.

This approval reflects the authority's ongoing commitment to supporting innovation and expanding access to advanced treatments, contributing to enhancing the quality of healthcare and aligning with the objectives of the "Health Sector Transformation" program, one of the main initiatives of "Saudi Vision 2030," and strengthens the country's regional and international status in the pharmaceutical regulation field.