Clinical data for conditional approval of regenerative medical products for cancer
| Project/Area Number |
15K20967
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Medical engineering assessment
Tumor therapeutics
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| Research Institution | The University of Tokyo |
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Principal Investigator |
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| Project Period (FY) |
2015-04-01 – 2018-03-31
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| Project Status |
Completed (Fiscal Year 2017)
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| Budget Amount *help |
¥4,030,000 (Direct Cost: ¥3,100,000、Indirect Cost: ¥930,000)
Fiscal Year 2017: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2016: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2015: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
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| Keywords | 抗癌剤 / 薬事承認 / 再生医療等製品 / 薬事規制 / 抗がん剤 |
|---|
| Outline of Final Research Achievements |
No regenerative medical products for cancer have been granted conditional approval in Japan. Oncologic drugs including regenerative medical products for hematological malignancy were analyzed. This analysis showed that US Food and Drug Administration has taken more active attitude to acceptance of surrogate endpoints in single-arm trials than European Medicines Agency and Pharmaceuticals and Medical Devices Agency. In addition, the approval of all indications approved first in the EU was based on results of comparative trials. In another analysis, we showed that significant superiority was demonstrated in only 6 phase 3 trials with a sufficient number of patients with relapsed lymphoid malignancy other than follicular lymphoma, chronic lymphocytic leukemia, and multiple myeloma.
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Report
(4 results)
Research Products
(43 results)
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[Journal Article] Societal challenges of precision medicine: Bringing order to chaos2017
Author(s)
Salgado R, Moore H, Martens JWM, Lively T, Malik S, McDermott U, Michiels S, Moscow JA, Tejpar S, McKee T, Lacombe D; IBCD-Faculty
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Journal Title
Eur J Cancer
Volume: 84
Pages: 325-334
DOI
Related Report
Peer Reviewed / Int'l Joint Research
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[Journal Article] Generic oncology drugs in developed and developing countries: are they all safe?2016
Author(s)
Yang YT*, Nagai S*, Chen BK* (*: co-first authors), Qureshi ZP, Lebby AA, Kessler S, Georgantopoulos P, Raisch DW, Sartor O, Hermanson T, Kane RC, Hrushesky WJ, Riente JJ, Norris LB, Bobolts LR, Armitage JO, Bennett CL
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Journal Title
Lancet Oncology
Volume: 17
Issue: 11
Pages: e493-e501
DOI
Related Report
Peer Reviewed / Int'l Joint Research
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