The FDA has approved Activia for the treatment of lung and bladder cancer

In a move reflecting the Kingdom of Saudi Arabia’s leadership in the medical and regulatory field, the Saudi Food and Drug Authority issued an official and conditional approval for the use of “Anktiva” – the scientific name (Nogabendikin alfa inbacept) – as a new and innovative treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) and high-risk bladder cancer.

With this decision, the Saudi Food and Drug Authority is the first regulatory body in the world to approve this drug for the treatment of lung cancer under specific conditions, highlighting the great progress that the Kingdom is making in quickly evaluating and approving modern treatments.

The innovative mechanism of action of the drug Activia

The new drug utilizes advanced technology that stimulates the patient's own immune system to fight cancer cells. According to the FDA, the drug binds to and activates interleukin-15 receptors, leading to the activation and proliferation of natural killer (NK) cells and T cells. The significance of this mechanism lies in its ability to selectively direct the immune system to attack the tumor while simultaneously limiting the proliferation of regulatory T cells, which typically suppress the immune response. This makes it a promising option within the field of immunotherapy.

Usage details for lung and bladder cancer

The drug was approved for two main conditions:

• Non-Surgical Cancer of Lung (NSCLC): Used as an adjunct to immunotherapies for patients whose condition has worsened after failure of standard treatments. Administered by subcutaneous injection. Approval was conditional, based on preliminary indications of improved survival rates, with the manufacturer required to conduct confirmatory studies to ensure long-term clinical benefit.
• Non-Microbladder Cancer (NMIBC): This is used for patients with high-risk, non-invasive bladder cancer who have not responded to standard treatment (BCG). It is administered via direct injection into the bladder. Studies have shown a complete response rate of 62%, offering new hope for this patient population.

Observed side effects

Based on clinical studies, the agency identified a range of potential side effects, which vary depending on the site of the injury:

• For bladder cancer patients: Symptoms may include elevated creatinine, painful urination, blood in the urine, frequent urination, urinary tract infection, muscle pain and fever.
• For lung cancer patients: These include injection site reactions (redness or itching), chills, fatigue, nausea, and flu-like symptoms.

The importance of the decision and keeping pace with Vision 2030

This accreditation enhances the treatment options available to patients who have exhausted traditional solutions, contributing to improved quality of life and better disease management. This achievement aligns with the objectives of the Health Sector Transformation Program, stemming from the Kingdom's Vision 2030, which aims to improve the efficiency of healthcare services and facilitate access to the latest therapeutic and pharmaceutical technologies, solidifying the Kingdom's position as a leading regional and international hub for pharmaceutical regulation and healthcare.