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 (PK), 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.

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