FDA's decisions in oncology drug product approvals from 2006 to 2016. Issue 4 (December 2018)

• Record Type: Journal Article
• Authors: Hyogo, Atsushi; Kaneko, Masayuki; Narukawa, Mamoru
• Is Part Of: Health policy and technology. Volume 7:Issue 4(2018)
• Page Start: 341
• Page End: 346
• Publication Date: 2018-12
• Subjects: Oncology drug product -- Drug approval -- FDA -- Regulatory decision; Medical policy -- Periodicals; Medical technology -- Periodicals; Medical policy; Medical technology; Health Policy -- Periodicals; Biomedical Technology -- Periodicals; Technology Assessment, Biomedical -- Periodicals; Periodicals; 362.105
• DOI: 10.1016/j.hlpt.2018.10.009
• Languages: English
• ISSNs: 2211-8837

Abstract

Highlights: Expedited programs are effective for a sooner delivery of desired oncology drugs. Expedited programs affect the review period but not the development period. The characteristics of pivotal studies on expedited development are validated. Abstract: Objective: Under the circumstances that several oncology drugs have been approved under expedited programs in the US, this study aimed to analyze the relationship between the expedited programs and characteristics of approvals in the recent decade, and the attitude of the Food and Drug Administration (FDA) toward the development and review of oncology drugs. Results: Of the 162 approvals that were analyzed, the proportion of orphan drug (OD) designation was higher in accelerated approval (AA) than regular approval (RA). In contrast, no difference was observed in the proportions of priority review (PR) in AA versus RA or in ODs versus non-ODs. In the development time, no difference was observed in any of the expedited programs. Regarding review time, a significant difference was observed in PR versus standard review (SR). In the characteristics of the pivotal study, such as randomization, number of patients, and endpoints, differences were observed in AA versus RA and in ODs versus non-ODs. Conversely, no significant difference was noted in PR versus SR. Conclusion: The overall results of this research validated the attitude of the FDA toward applying each expedited program to facilitate an earlier delivery of innovative oncology drug products to patients with cancer.