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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.
Daiichi Sankyo announces an extension was issued for the review period of its New Drug Application (NDA) for quizartinib by the US Food and Drug Administration (FDA). The drug is intended to treat adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.1
The FDA has shifted the Prescription Drug User Fee Act (PDUFA) action date back 3 months to July 24, 2023. According to the statement, no additional safety or efficacy data has been requested and the extension will provide time for the agency to review updates to the proposed Risk Evaluation and Mitigation Strategies (REMS) included in the application.
The global healthcare company stated it is working closely with the agency to facilitate the completion of the quizartinib new drug application, which has the potential to change the standard of care for patients with the rare condition.
The drug’s application included data from the QuANTUM-First study, a phase 3 randomized, double-blind, placebo-controlled trial that evaluated quizartinib in combination with standard chemotherapy for the treatment of adult patients with newly diagnosed FLT3-ITD positive AML.
Study data showed the safety of quizartinib combined with intensive chemotherapy and as continuation monotherapy in QuANTUM-First was generally manageable with no new safety signals observed. The incidence of grade ≥3 QT prolongation events was low, with uncommon ventricular arrhythmia events.2
A total of 539 patients from 193 study sites across Asia, Europe, North America, Oceania, and South America, were randomized 1:1 into 2 treatment groups to receive quizartinib or placebo combined with anthracycline- and cytarabine-based regimens. The primary endpoint was overall survival, and secondary endpoints included event-free survival, rates of complete remission, and safety and pharmacokinetics.
Eligible patients, including those who underwent hematopoietic stem cell transplant, continued with quizartinib or placebo for up to 36 cycles. It was noted that the risk of QT prolongation was manageable with ECG monitoring, quizartinib dose modification, and correction/elimination of additional risk factors.
“Quizartinib was shown to improve overall survival when added to standard chemotherapy and continued as monotherapy and has potential to change the standard of care for patients with newly diagnosed FLT3-ITD positive AML,” Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo, stated.