%0 Journal Article
%T Factors That Influence FDA Decisions for Postmarketing Requirements and Commitments During Review of Oncology Products
%A Atsushi Hyogo
%A Mamoru Narukawa
%A Masayuki Kaneko
%J General Information | Journal of Oncology Practice
%D 2018
%R https://doi.org/10.1200/JOP.2017.023234
%X INTRODUCTION Section: ChooseTop of pageAbstractINTRODUCTION <<METHODSRESULTSDISCUSSIONREFERENCES During the past decades, there has been a notable increase in the number of drugs approved under expedited programs in the United States,1 such as fast-track designation, orphan drug designation, breakthrough therapy designation, and accelerated approval (AA)¡ªin particular, for oncology products. Kesselheim et al2 reported that, for oncology drugs, 76% (81 of 107 drugs) were approved with priority review, 61% (65 of 107 drugs) were orphan drugs, 48% (51 of 107 drugs) had a fast-track designation, and 30% (32 of 107 drugs) received AA between 1987 and 2014.2 The US Food and Drug Administration (FDA) has been more flexible and has widely accepted the use of surrogate and intermediate end points rather than a clinical benefit end point, such as overall survival,3 and has approved late-line therapies with single-arm trials in refractory populations.4 Under these conditions, accumulated data and evidence in the postmarketing setting have become more important. Jena et al5 noted the growing importance of postmarketing review and pointed toward an approach that would grant short-term access to novel drugs on the basis of early evidence but would mandate long-term data from hard end points for that access to continue.5 Furthermore, the flexibility of the FDA is not limited to approvals under the expedited programs but has expanded to traditional regular approvals (RAs) for products that are based on the seriousness of the disease and the availability of effective therapies as well as have shown effects on surrogate or intermediate end points.6 Therefore, the importance of postmarketing plans, including postmarketing requirements (PMRs) and postmarketing commitments (PMCs), has increased to confirm the clinical benefits of approved drugs. PMR/PMCs for studies and clinical trials occur after a drug or biologic product has been approved by the FDA. The 2007 FDA Amendments Act (FDAAA) specifically provided the FDA with the authority to require sponsors to conduct PMR/PMCs.7 The FDA guidance provides several examples of PMRs, many of which are focused on safety evaluations of drug products, and some are conducted for efficacy evaluations along with safety. There are some research studies about the characteristics of products approved by the FDA under AA,4,8,9 but to our knowledge no study has considered PMR/PMCs. Given this background, we investigated the factors that influenced the FDA decisions for PMR/PMCs during FDA review of oncology products. METHODS Section:
%U http://ascopubs.org/doi/full/10.1200/JOP.2017.023234