Ugandan-developed Cancer Drug Gets FDA Guidance on Path to Market

Ugandan scientist Matthias Magoola is a step closer to bringing a more affordable cancer treatment to market, thanks to recent guidance from the U.S. Food and Drug Administration (FDA). On July 14, the FDA provided detailed feedback to Magoola’s company, Dei BioPharma, regarding PSI-033, a proposed biosimilar version of the immunotherapy drug Yervoy.

While this does not signify approval, the FDA’s comments outline the necessary steps, evidence, and manufacturing standards required before Dei BioPharma can apply to sell the drug in the United States. This early guidance is crucial for saving time and resources in the lengthy drug development process.

PSI-033 is being developed as a biosimilar to Yervoy, a widely used cancer treatment. Biosimilars are highly similar to approved biological medicines and are designed to work in the same way, offering a more cost-effective alternative. Yervoy, developed by Bristol Myers Squibb, is an expensive but vital treatment for several types of cancer, making biosimilar versions highly sought after.

According to Dei BioPharma, the FDA found several aspects of their development program promising, including the drug’s formulation, stability testing, and viral clearance processes. Crucially, the FDA suggested that certain animal and clinical efficacy studies might be waived if sufficient laboratory evidence demonstrates PSI-033’s high similarity to Yervoy. This could significantly shorten the development timeline and reduce costs.

However, the FDA also advised caution, recommending against using healthy volunteers for pharmacokinetic studies due to potential safety risks associated with Yervoy. Dei BioPharma must gather comprehensive safety data to address these concerns.

“The FDA’s detailed preliminary comments give us a clear, product-specific roadmap for strengthening the analytical package, completing the clinical-pharmacology programme and preparing PSI-033 for a future US licensing application,” stated Magoola.

The commercial potential is substantial, with Yervoy generating billions in sales annually. Dei BioPharma aims to submit its application for PSI-033 within approximately nine months, contingent on completing the remaining studies and maintaining alignment with FDA requirements. The company is also developing a biosimilar for another major cancer drug, Opdivo, aiming to build global manufacturing capacity in Uganda and improve access to essential medicines.

Source: https://observer.ug/news/fda-opens-door-for-ugandas-cancer-drug