Comparing cancer drug approval systems in the United States and Japan

A recent example of confusion brought by such differences in the regulatory approval systems is the case of Tecentriq (atezolizumab) in treating patients with advanced triple-negative breast cancer whose tumors express PD-L1. In the United States, the drug received approval in February 2008 as a treatment for breast cancer when used in conjunction with paclitaxel, based on the findings from the E2100 trial. 5 Nevertheless, in November 2011, the FDA rescinded its approval, citing the outcomes of the AVADO and RIBBON1 studies, which failed to exhibit a definitive life-extending effect. 5 Contrarily, in Japan, the authorization of bevacizumab combined with paclitaxel for breast cancer treatment, approved in September 2011, remains in effect. Since the regulatory authorities for drugs in each country make independent decisions, they would not necessarily be required to follow or harmonize the authorities’ decisions in other countries. [...]as the most influential regulatory authority in the world, the US FDA's far-reaching influence is not negligible, and countries without the AA pathway, including Japan, must be aware of the problem and should note that, even after approval, it is essential to continuously evaluate the drug's efficacy as a treatment option and ensure that patients benefit from its use.