A critical appraisal of Japan's new drug approval process: a case study of FLT3-ITD inhibitor quizartinib
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,Oncology
Link
https://link.springer.com/content/pdf/10.1007/s10637-021-01151-0.pdf
Reference10 articles.
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3. Tanimoto T, Tsubokura M, Mori J, Pietrek M, Ono S, Kami M (2013) Differences in drug approval processes of 3 regulatory agencies: A case study of gemtuzumab ozogamicin. Invest New Drugs 31(2):473–478. https://doi.org/10.1007/s10637-012-9877-8
4. Larrosa-Garcia M, Baer MR (2017) FLT3 Inhibitors in acute myeloid leukemia: Current status & future directions. Mol Cancer Ther 16(6):991–1001. https://doi.org/10.1158/1535-7163.MCT-16-0876
5. Cortes JE, Khaled S, Martinelli G et al (2019) Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol 20(7):984–997. https://doi.org/10.1016/S1470-2045(19)30150-0
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