Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
Hwang, Thomas J. (Brigham and Women's Hospital (Boston, Estats Units d'Amèrica))
Kesselheim, Aaron S. (Brigham and Women's Hospital (Boston, Estats Units d'Amèrica))
Tibau Martorell, Ariadna (Institut d'Investigació Biomèdica Sant Pau)
Lee, ChangWon C. (Brigham and Women's Hospital (Boston, Estats Units d'Amèrica))
Vokinger, Kerstin N. (Institute of Law, University of Zurich, Zurich, Switzerland)
Universitat Autònoma de Barcelona

Data:	2022
Resum:	We studied all new cancer drugs approved in the six aforementioned jurisdictions from 2007 to 2020. We extracted all applicable expedited programs, total regulatory review times, and, for drugs first approved by the FDA, times to subsequent regulatory approval. Clinical benefit was assessed using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale value framework and ASCO-Cancer Research Committee's targets. Nonparametric Kruskal-Wallis test was used to compare total review times for high versus low clinical benefit drugs. One hundred and twenty eight drugs received initial approval in at least one of the six included jurisdictions. Most drugs approved by the FDA (91%) and Health Canada (59%) qualified for at least one expedited program within those jurisdictions, compared with 46% of EMA approvals and 18% of PMDA approvals. The FDA was the first regulator to approve 102 (80%) drugs. Delays in submission accounted for a median of 20. 2% (EMA) to 83. 8% (PMDA) of the time to subsequent approval. There was no association between high clinical benefit and shorter total review times. Most new cancer therapies were approved first by the FDA, and delays in submission of regulatory applications accounted for substantial delays in approving cancer drugs in other countries. Regulators should prioritize faster review for drugs with high clinical benefit.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	JCO Oncology Practice, Vol. 18 (june 2022) , p. e1522-e1532, ISSN 2688-1535

DOI: 10.1200/OP.21.00909
PMID: 35731996

12 p, 430.7 KB

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