FDA accepts New Drug Listing Application for Gilteritinib for AML Adult Patient Treatment
-
Last Update: 2020-06-11
-
Source: Internet
-
Author: User
Search more information of high quality chemicals, good prices and reliable suppliers, visit
www.echemi.com
acute myeloid leukemia (AML) is a blood malignant tumor with abnormal proliferation of bone marrow hematopoietic bud cells, and is the most common acute leukemia in adults, Japan's AstellasPharmaceuticals(announced that the U.SFDA(has accepted gilteritinib for the
treatment of fltinib for recurrent or refractory acute myeloid leukemia (AML) adult patients(listing application (NDA) and given priority reviewrelated studies
This NDA is based on an ongoing study of the efficacy of gilteritinib in treating recurrent or refractory AML adult patients with a clinical phase 3 ADMIRAL
trial()The FDA's Prescription Drug User Fees Act (PDUFA) target date is November 29, 2018thedrug(if approved) have significantly improved the safety and effectiveness of treatment for serious diseases compared to standard treatments, as determined by the FDAUnder the priority review, the FDA aims to make a review decision on the application within six months of receipt of the application, compared with 10 months for the standard procedureGilteritinib inhibits FLT3 in-line repetitive (ITD) and FLT3 tyrosine kinase domain (TKD)study found that the drug also showed inhibition softos on AXLPreviously, Gilteritinib had been awarded orphan drugs and fast-track designations by the FDA and designated as orphan drugs by the European Commission (EC) and the Ministry of Health, Labour and Welfare (MHLW) of JapanMHLW also granted the SAKIGAKE designation for the drug relapse/difficult yIntotic AML therapy
This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only.
This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of
the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed
description of the concern or complaint, to
service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content
will be removed immediately.
