Press Release Quizartinib NDA Review for Patients with Newly Diagnosed FLT3- ITD Positive AML Extended by FDA Tokyo and Basking Ridge, NJ - . | April 20, 2023
The FDA has extended the review period for a new drug application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of newly diagnosed adult patients with FLT3-ITD–positive acute myeloid leukemia.
The FDA requests no additional safety or efficacy data, the extension will provide time for the agency to review updates to the proposed Risk Evaluation and Mitigation Strategies (REMS) included in the application.
Patritumab Deruxtecan Continues to Show Encouraging Clinical Activity in Distinct Patient Populations with Metastatic Lung and Breast Cancer in Updated Results of Two Early Trials streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.