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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230427006072/en/
About Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
CA-PSMF3.6.2023 07:12:31 CEST | Press release
The Patient Safety Movement Foundation Concludes Its 10th Annual World Patient Safety, Science & Technology Summit
HALLYM-UNIVERSITY2.6.2023 11:01:34 CEST | Press release
Ilsong Educational Foundation Chairman Dai-Won Yoon Wins Linnaeus Medal as the First in Asia
CA-PSMF2.6.2023 08:16:30 CEST | Press release
10th Annual World Patient Safety, Science & Technology Summit Begins
AUTEL-ENERGY2.6.2023 08:01:28 CEST | Press release
Autel Energy Holds Partner Summit in Amsterdam, Mapping Out Europe Strategy
PL-BIOSCIENCE-GMBH2.6.2023 07:23:26 CEST | Press release
PL BioScience and Macopharma enter into a Patent License and Assignment Agreement regarding Human Platelet Lysate (HPL) cell culture supplements.
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom