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Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals.
Hakariya, Hayase; Moriarty, Frank; Ozaki, Akihiko; Mulinari, Shai; Saito, Hiroaki; Tanimoto, Tetsuya.
Afiliación
  • Hakariya H; Interfaculty Institute of Biochemistry, University of Tuebingen, Tuebingen, Germany.
  • Moriarty F; Institute for Pharmaceutical and Social Health Sciences, Ise, Japan.
  • Ozaki A; School of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, Dublin, Ireland.
  • Mulinari S; Breast and Thyroid Center, Jyoban Hospital of Tokiwa Foundation, Iwaki, Fukushima, Japan.
  • Saito H; Medical Governance Research Institute, Tokyo, Japan.
  • Tanimoto T; Department of Sociology, Lund University, Lund, Sweden.
Clin Transl Sci ; 17(7): e13879, 2024 Jul.
Article en En | MEDLINE | ID: mdl-38987923
ABSTRACT
Regulatory authorities must balance ensuring evidence of efficacy and safety of new drugs. Various regulatory pathways, such as the accelerated approval program in the United States (US), allow authorities to quickly approve drugs for severely ill patients by granting market authorization based on surrogate end points and pending confirmatory trials. In this cross-sectional study, we considered 23 indications of cancer drugs that received accelerated approval by the US Food and Drug Administration (FDA) but were subsequently withdrawn as of April 2023. Our investigation extended to assessing the regulatory status of these accelerated approvals in the European Union (EU) and Japan, examining relevant regulatory documents and identifying factors contributing to the withdrawal in the United States. Comparing regions, we found that for 52% (12/23) and 30% (7/23) of withdrawn accelerated approvals in the United States, sponsors had also sought marketing authorization from the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), respectively. As of the April 30, 2023 study cutoff date, 83% (10/12) of drug-indication pairs remained approved by the EMA, while the PMDA retained 100% (7/7). For these indications, the time from FDA withdrawal until the study cutoff date ranged from 0.23 years to 11.45 years for EMA approvals (median 1.28 years) and 1.10 years to 11.45 years for PMDA approvals (median 3.22 years). These findings highlight substantial regulatory discrepancies concerning cancer drugs with unconfirmed benefits. Addressing these discrepancies may involve requiring pharmaceutical companies to confirm clinical benefits using more robust end points and fostering international harmonization in regulators' assessment.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Aprobación de Drogas / Antineoplásicos Límite: Humans País/Región como asunto: America do norte / Asia / Europa Idioma: En Revista: Clin Transl Sci Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Aprobación de Drogas / Antineoplásicos Límite: Humans País/Región como asunto: America do norte / Asia / Europa Idioma: En Revista: Clin Transl Sci Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos