2017 Fiscal Year Final Research Report
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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| Keywords | 抗癌剤 / 薬事承認 / 再生医療等製品 |
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| 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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| Free Research Field |
規制科学
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