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

2023年05月15日 PM03:10
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TOKUSHIMA, Japan

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 2nd, 3rd, or 4th salvage of AML and the 1st 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230427006072/en/

CONTACT

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/

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