Influence of Breakthrough Therapy Designation in the United States on Oncology Drug Development Timelines in Japan

Abstract

The Breakthrough Therapy Designation (BTD) program was established in the USA in 2012 to expedite the development of new potential “breakthrough” drugs with promising early clinical evidence over available therapies. The majority of BTDs are oncology drugs, and previous research has reviewed the impact of this designation on drug development in the USA. Recent trends in the globalization of oncology drug development suggest that expedited programs in the USA may influence drug development timing in other countries. We examined the influence of BTD in the USA on the development initiation date, development period, and approval of oncology drugs in Japan. We analyzed oncology drugs approved in Japan between 2013 and 2017 that were also approved in the USA. The development period was calculated by subtracting the start date of the first clinical study or the investigational new drug application date from the drug approval date in the respective country. All data were obtained from publicly disclosed information. We analyzed 72 approvals for oncology drugs. The development periods for BTD drugs, both in Japan and in the USA, were shorter than those for non-BTD drugs. Additionally, the difference both in the development start date and in the approved date between the USA and Japan was smaller for BTD drugs than that for non-BTD drugs. BTD designation itself and/or the characteristics and target diseases of drugs that are eligible for BTD in the USA may constitute factors that facilitate a shorter development period, earlier development initiation and earlier approval in Japan.