Daiichi's AML Drug Quizartinib Heads To ODAC With Host Of Efficacy, Safety Issues
Executive Summary
US FDA's Oncologic Drugs Advisory Committee will examine Daicchi Sankyo's acute myeloid lekemia drug quizartinib in the second of two half-day panels for the sponsor.
You may also be interested in...
Keeping Track: FDA OKs AMAG's Vyleesi, But Bronchitol And Quizartinib Draw CRLs
The latest drug development news and highlights from our US FDA Performance Tracker.
Daiichi’s Quizartinib And The Quintessential 'Pazdur Moment'
Daiichi Sankyo made a strong case to rebut US FDA’s concerns about the 'credibility' of a survival benefit reported for its refractory AML therapy quizartinib in front of the Oncologic Drugs Advisory Committee. Then Richard Pazdur spoke.
Quizartinib Looks Like A Good Drug, ODAC Says, But Needs Another Efficacy Trial Before Approval
US FDA's Oncologic Drugs Advisory Committee voted 8-3 against approval for Daiichi's quizartinib, although panelists felt the acute myeloid leukemia candidate would be approvable with another trial to better characterize its efficacy.