Phase 3 Study of DFP-10917 in the R/R AML Patients Shall Be Done with the 1st Interim Analysis for NDA Approval.

TOKUSHIMA, Japan–(BUSINESS WIRE)–150 patients have been enrolled at the multi-clinical centers in US to the Phase 3 randomized trial of DFP-10917 vs non-intensive reinduction (LoDAC, Azacytidine, Decitabine, Venetoclax combo-regimens) or intensive reinduction (high and intermediate dose of Cytarabine regimens) in the 2^nd, 3^rd, or 4^th salvage of AML and the 1^st interim analysis of this study shall be done for NDA approval to the FDA in US soon after confirmation of the superiority of DFP-10917 arm. The endpoint is CR rate for primary and the Overall Survival for secondary. DFP-10917 (Radgocitabine) was granted as Orphan Drug Designation (ODD) by the FDA in US.

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Inquiries:

Yasuo Matsueda

Vice President for Business Development

Delta-Fly Pharma, Inc.

Head office: Tokushima 771-0116, Japan

Phone: +81-(0)3-6231-1278

E-mail: ymatsueda1206@delta-flypharma.co.jp
Home page: https://www.delta-flypharma.co.jp/