PCN72 APAC Overview of the Accelerated Approval Pathways: Applications in LUNG Cancer

Abstract

Speeding up the delivery of drugs that treat serious diseases helps ensure timely access to important therapeutic interventions. The aim of this review is to provide holistic view of the different accelerated regulatory approval pathways across the APAC region and the potential applications in lung cancer. Lung cancer is by far the leading cause of cancer death worldwide and the most common cancer in Asia. A literature review was conducted using different sources such as government websites, ISPOR articles, pubmed and google scholar The purpose of the review was to enable the regulatory pathway to be mapped and in doing so identify different accelerated approval pathways; past, current and future trends and the potential application in lung cancer across the APAC region. A comparison of the different accelerated approval pathways versus standard approval pathways for Japan, China and Taiwan provides insights into differences in time to regulatory approval (Differences in timeline: JP:9 versus 12 months; CN:6 months or less versus 15 to 40 months; TW: 6-8 versus 12 months), enabling faster access to innovative therapies. Significant reforms have been introduced across Japan, China, Taiwan, Singapore and South Korea on expedited pathways for diseases with unmet needs, while Hong Kong providing priority review based on official requests from hospital authorities in urgent situation based on unmet needs. These reforms have been applied across different innovative therapies, including accelerated approval of lung cancer medicines. Overall, there is great diversity in the accelerated approval pathways across the APAC region with a variety of initiatives been undertaken aimed at accelerating access which have potential applications in lung cancer. The majority of the APAC countries are working towards regulatory reforms to speed up review processes through the introduction of various expedited pathways to enable faster approval of drugs based on the unmet needs.