Toward Optimum Benefit‐Risk and Reduced Access Lag For Cancer Drugs in Asia: A Global Development Framework Guided by Clinical Pharmacology Principles

Delay in approval (“drug lag”) of new anticancer therapies in Asia has led to increased interest in simultaneous global clinical development inclusive of Asia. Anticancer agents often have a narrow therapeutic window, making characterization of pharmacokinetics (PKs), pharmacodynamics, and safety crucial for maximizing benefit/risk in Asian populations. Herein, we present a global oncology drug development framework informed by quantitative clinical pharmacology, including an exposure-matched dosing strategy when clinically significant PK differences are encountered in Asia. Cancer is among the leading causes of death worldwide. It has been estimated that>14million new cases of cancer and >8 million cancer-related deaths occurred in 2012.1 Based on predictions of population growth in different regions of the world, the number of new cancer cases may reach more than 20 million annually by 2030.2 Of note, Asia is estimated to account for half the global burden of cancer.3 In order to meet the expected need for treatment, drug development strategies should include a global focus to ensure broad worldwide availability and access to new anticancer drugs. Global development strategies inclusive of Asia will be particularly important for malignancies that are more common in Asian regions, such as hepatic, gastric, and esophageal cancer,1 although a global approach is equally valuable for the development of drugs for other cancers (e.g., colorectal, breast, and lung cancers) that are becoming more prevalent in Asian countries as a consequence of an increasingly Western lifestyle and diet, and changes in smoking patterns.2 Drug development and approval in Asian countries often lag behind those of Europe and North America, and there is a significant unmet need to improve access to drugs for patients in Asia. Delays in access arise in part from specific regulatory requirements for local patient data across Asia (e.g., Japan, China, and Taiwan). For example, to receive approval in Japan from the Pharmaceuticals and Medical Devices Agency, clinical safety and efficacy data from Japanese patients must be part of the submission. To help