| 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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| 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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