FDA extends review of Daiichi Sankyo's AML drug quizartinib
23 Apr 2023
Phase 3AcquisitionPriority ReviewNDADrug Approval
Daiichi Sankyo announced that the FDA extended its review of the company's filing seeking approval of quizartinib for patients with newly-diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive. The action date has been pushed back by three months to July 24 to allow more time to assess requested updates to the proposed Risk Evaluation and Mitigation Strategies (REMS), although the FDA has not asked to see additional efficacy or safety data.
The filing was granted a priority review last October. Daiichi Sankyo is seeking approval of quizartinib for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for adults with newly diagnosed FLT3-ITD-positive AML.
Overall survival benefit
The application is based on results from the Phase III QuANTUM-First trial. Findings presented at the European Hematology Association (EHA) congress last year showed that quizartinib combined with standard induction and consolidation chemotherapy, and then continued as a single agent, reduced the risk of death by 22.4% compared to standard chemotherapy alone. Median overall survival (OS) was more than double at 31.9 months for patients on quizartinib, compared to 15.1 months for those receiving chemotherapy.
Meanwhile, Daiichi Sankyo said rates of Grade 3 or higher treatment-emergent adverse events (TEAEs) were similar for both groups, with the most common being febrile neutropenia, neutropenia, hypokalemia and pneumonia. Rates of TEAEs associated with fatal outcomes were 11.3% for quizartinib versus 9.7% chemotherapy alone and were mainly due to infections.
According to the company, the incidence of Grade ≥3 QT prolongation events was "low," while ventricular arrythmia events were "uncommon." However, two patients experienced cardiac arrest with recorded ventricular fibrillation on ECG, including one who died, with both cases occurring in the setting of severe hypokalemia. Daiichi Sankyo said the overall risk of QT prolongation was "manageable" with ECG monitoring, quizartinib dose modification and correction/elimination of additional risk factors.
Prior complete response letter
In a statement announcing the FDA delay, the company's global head of oncology clinical development Mark Rutstein suggested the oral FLT3 inhibitorFLT3 inhibitor could potentially "change the standard of care" for patients with newly diagnosed FLT3-ITD positive AML. "We are continuing to work with the FDA to facilitate completion of their review of the quizartinib new drug application" to allow patients to receive the drug "as soon as possible," he added.
Daiichi Sankyo's first attempt to secure a US nod for quizartinib failed in 2019 after an advisory panel voted against recommending approval, concluding that the benefits of the drug did not outweigh its potential risks based on data from another Phase III trial, QuANTUM-R. The therapy was cleared that year in Japan under the name Vanflyta for the treatment of adults with relapsed/refractory AML that is FLT3-ITD positive. Daiichi Sankyo acquired quizartinib, which is also under review in Europe and Japan for newly-diagnosed patients, as part of its $410-million takeout of Ambit Biosciences in 2014.
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