We Need a Global System for Testing and Approving Cancer Treatments

Bobby Daly, Justin Finnegan, Bob T. Li, and Jing Qian

Harvard Business Review, October 18, 2022

The lack of a standardized international system for approving new cancer therapies undergoing clinical trials has led to the loss of approximately 2 million lives each year. The authors propose that by establishing harmonized regulations for oncology therapies’ approvals globally, the number of annual cancer-related deaths could be reduced by 10% to 20%, saving 1 to 2 million lives. They highlight the success of the U.S.’s Project Orbis, an initiative by the FDA Oncology Center of Excellence, in streamlining the approval process for new cancer treatments and suggest expanding this framework internationally. Standardizing criteria across participating nations would expedite drug approvals, making treatments accessible to patients sooner, consequently extending the lives of those in critical need.

The article delves into the potential impact of concurrent international regulatory approvals by examining specific case studies of two drugs – pembrolizumab and enzalutamide. The FDA approved pembrolizumab for metastatic non-small cell lung cancer (NSCLC) in 2016, significantly prolonging the lives of patients. However, delays in approvals in other countries have prevented patients from benefiting from this life-saving drug. Similarly, enzalutamide, approved by the FDA in 2012 for late-stage prostate cancer, faced delays in global approvals, particularly in China. The authors estimate that hundreds of thousands of patient life-years could have been saved if these drugs had been approved globally simultaneously with the U.S.

To establish a global system, the authors propose several key steps, including strengthening regulatory bodies, defining requirements for ethnicity-specific trials, standardizing manufacturing inspections, planning for approvals in secondary markets, and reforming insurance coverage for life-prolonging treatments. These measures aim to streamline the drug approval process, accelerate patient access to innovative treatments, and ultimately reduce the staggering number of cancer-related deaths worldwide. The authors acknowledge the challenges in implementing these changes but emphasize the urgent need to address the significant loss of lives to cancer each year, making the effort worthwhile and crucial.

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