Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan.
In: Therapeutic Innovation & Regulatory Science, Jg. 58 (2024), Heft 1, S. 136-142
Online
academicJournal
Zugriff:
The accelerated approval (AA) program in the USA has succeeded in expediting the regulatory approval of new cancer drugs based on surrogate endpoint data. It is unclear whether the AA program promotes overall drug development, including verification of the clinical benefit, as the verification of drugs granted AA often takes long time. To determine the impact of the AA program on overall drug development, the time required for verification of clinical benefits was compared between anticancer drugs that initially received AA and those that received regular approval (RA). It was found that anticancer drugs that were approved under the AA program took longer time for verification, suggesting that the program may delay the start of a confirmatory study, and there may be room for speeding up the process. In addition, discordance was found in the pivotal study between the USA and the EU and the USA and Japan for obtaining the indication for which AA was granted in the USA and a delay in the start of the confirmatory study for the AA indication was considered to lead to a delay in approval in the EU and Japan. Early initiation of confirmatory studies for AA indications is recommended to reduce the time that patients receive drugs with unproven benefit in the USA, as well as to deliver innovative new drugs to patients earlier in the EU and Japan. [ABSTRACT FROM AUTHOR]
Copyright of Therapeutic Innovation & Regulatory Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Titel: |
Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan.
|
---|---|
Autor/in / Beteiligte Person: | Ito, Akira ; Narukawa, Mamoru |
Link: | |
Zeitschrift: | Therapeutic Innovation & Regulatory Science, Jg. 58 (2024), Heft 1, S. 136-142 |
Veröffentlichung: | 2024 |
Medientyp: | academicJournal |
ISSN: | 2168-4790 (print) |
DOI: | 10.1007/s43441-023-00577-3 |
Schlagwort: |
|
Sonstiges: |
|