The following is an excerpt of Asia Society Policy Institute Center for China Analysis Managing Director Jing Qian and Senior Fellow Dr. Bob Li's article co-authored with Bobby Daly and Justin Finnegan, originally published in Harvard Business Review. 

By globally harmonizing regulations for the approval of oncology therapies subject to clinical trials, it would be possible to reduce the number of global cancer-related deaths per year by 10% to 20%, or 1 million to 2 million lives. That’s because the lack of such an international system is slowing the approval of treatments around the world, according to research that we conducted.

The United States has already made significant progress in setting up an international regulatory infrastructure for the simultaneous review and potential approvals of new cancer treatments with Project Orbis, an initiative of the Food and Drug Administration (FDA) Oncology Center of Excellence. The task ahead is to take that framework and further internationalize it. The goal would be to have clinical trials in all participating nations follow the same criteria, which would allow a company seeking approval of an anti-cancer drug to submit one set of applications to regulators in those countries, permit those regulators to review such applications concurrently, and facilitate a dialogue among them on how to improve global clinical trials. Drugs would get approved faster, become available to more patient populations sooner, which would prolong the lives of those who are in critical need of treatment.

We evaluated how the simultaneous international regulatory approvals of two specific drugs would have benefited patients around the world. The first was pembrolizumab, which the FDA approved in 2016. It is a type of immunotherapy used to treat patients with metastatic non-small cell lung cancer (NSCLC), the most common type of lung cancer, whose tumors express a protein, PD-L1. As the first immunotherapy approved as a frontline-treatment option for lung cancer, pembrolizumab changed the treatment landscape for patients: the phase III trial found that for patients with tumors that had high expression of PD-L1 (about 30% of advanced non-small cell lung cancers), pembrolizumab reduced the risk of death by 38% compared to chemotherapy, and patients who took it lived on average 13 months longer with nearly a third of patients still alive at five years after starting treatment for stage 4 lung cancer.

But the approval was confined to the United States. The drug experienced approval delays in other countries, and it is still not available in many countries. Based on a retrospective analysis, we estimate that over 600,000 patient life years could have been saved in the six countries and regions with the highest cancer burden (Japan, the European Union (EU), Brazil, Canada, India, and China) if pembrolizumab had been approved worldwide at the same time it was approved in the United States. This translates to almost 850,000 life years when scaled to the global patient population.

The second treatment we looked at was enzalutamide, an androgen receptor inhibitor for prostate cancer. This is the second-most-diagnosed cancer and the fifth-leading cause of cancer mortality among men globally. The FDA first approved enzalutamide in 2012 for patients with metastatic castrate-resistant prostate cancer (mCRPC), a late-stage prostate cancer. The drug significantly improved patient outcomes: The phase III trial showed an incremental overall survival benefit of 4.8 months, on average, compared to the placebo. However, internal regulatory delays occurred in other countries. We estimate that 284,000 patient life years could have been saved in Japan, the EU, Brazil, Canada, India, and China if enzalutamide had been approved globally at the same time it was approved in the United States.

China offers the largest opportunity. An estimated 500,000 patient life years could be saved through harmonization of trial requirements that have delayed patient access to treatment by patients in that country. For example, enzalutamide was not approved in China for mCRPC until November 2019, seven years after the U.S. approval. The lag was largely driven by a separate Asian multinational phase III trial that was conducted to meet China’s specific regulatory requirements. This delay illustrates the importance for greater standardization and acceleration of global regulatory processes. In recent years, however, China has been making significant strides to accelerate drug approvals. For example, as part of regulatory reforms, the requirement for China-specific trials was removed provided the foreign drug maker conducted international, multicenter trials that included China as a site.

Read the full article in Harvard Business Review.