Announced details
Relapsed/refractory acute myeloid leukemia (R/R AML), second-line AML, and patients with R/R AML harboring TP53 mutations
DFP-10917 monotherapy demonstrated greater efficacy than intensive chemotherapy in a U.S. Phase 3 clinical trial. An incremental benefit was observed with the combination therapy. Quantitative data: Not disclosed
The counterparty with which the company will hold consultations regarding a conditional NDA for DFP-10917 and a Phase 3 clinical trial
The U.S. Food and Drug Administration. Other details: Not disclosed
RADBALGO: International Registration No. 1600230; RADGAZEN: International Registration No. 1600256. Expiration date: Not disclosed
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
U.S. FDA (Food and Drug Administration)
| Item | Details |
|---|---|
| Names of Products / Services Covered | DFP-10917（Radgocitabine）, RADBALGO, RADGAZEN, Combination therapy of DFP-10917 and venetoclax |
| Counterparty | U.S. FDA (Food and Drug Administration) |
| Counterparty overview | The U.S. Food and Drug Administration. Other details: Not disclosed |
| Relationship with the Company | The counterparty with which the company will hold consultations regarding a conditional NDA for DFP-10917 and a Phase 3 clinical trial |
| Applicable area | Relapsed/refractory acute myeloid leukemia (R/R AML), second-line AML, and patients with R/R AML harboring TP53 mutations |
| Registration number and expiry date | RADBALGO: International Registration No. 1600230; RADGAZEN: International Registration No. 1600256. Expiration date: Not disclosed |
| Quantitative Effects | DFP-10917 monotherapy demonstrated greater efficacy than intensive chemotherapy in a U.S. Phase 3 clinical trial. An incremental benefit was observed with the combination therapy. Quantitative data: Not disclosed |
| Source | U.S. FDA (Food and Drug Administration) |
Items this document does not state (10)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Completing international registration, including in China, will enable sales worldwide under the same product names. In addition, the company is preparing for FDA consultations toward a conditional NDA for DFP-10917 monotherapy, in light of major Western pharmaceutical companies’ interest in licensing in the sales and manufacturing rights. Consultations regarding the combination therapy are being pursued because favorable results were obtained in the Phase 1/2 trial.