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.
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Keeping Track: AZ’s Imjudo, J&J’s Tecvayli Enter Burgeoning Immuno-Oncology Market; Genmab Submits Epcoritamab
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Daiichi Sankyo is aiming to overcome past US and EU setbacks for its FLT3 inhibitor Vanflyta with planned filings for first-line AML on the back of positive new Phase III data.
Following green lights in the US and Japan, Xospata has been approved for relapsed or refractory FLT3-positive acute myeloid leukemia. Getting first-line approval is the next step.