LAUSR

I t is an unfortunate reality that not all patients with cancer have access to the drugs that could effectively treat their disease. Creating and implementing a global system for testing and approving cancer therapies could save millions of lives each year by speeding up the availability of new drugs to all patients who need them. “A global regulatory system would allow cancer drugs to reach patients faster and help us in our mission of prolonging and saving lives,” says Robert Daly, MD, MBA, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York, New York. An added benefit, he says, is the ability to allow cancer drugs to reach more diverse patient populations to improve the understanding of cancer and the development of more effective treatments. In an article recently published in the Harvard Business Review, Dr Daly and his colleagues detail the need for a global system for testing and approving cancer treatments and recommend five steps that countries can take worldwide to build such a system.1 Using the example of two specialized drugs—pembrolizumab and enzalutamide—they show that a global system that harmonizes regulations between countries could have saved an estimated 600,000 patient lives with pembrolizumab and an estimated 284,000 patient lives with enzalutamide in countries where approval of these drugs lagged behind US Food and Drug Administration (FDA) approval. Extrapolating from this analysis, they estimate that 1 million to 2 million lives could be saved by globally harmonizing regulations for novel cancer drugs approved each year by the FDA.