Daiichi Sankyo has received a positive recommendation for the approval of quizartinib in the European Union (EU). This recommendation is specifically for quizartinib’s use in combination with standard cytarabine and anthracycline induction, followed by standard cytarabine consolidation chemotherapy, and subsequent single-agent maintenance therapy with quizartinib. This treatment regimen is intended for adult patients who are newly diagnosed with acute myeloid leukemia (AML) and have a FLT3-ITD positive status.
The recommendation was provided by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The decision was primarily based on the results from the phase 3 QuANTUM-First trial, which were published in The Lancet. The next step involves the European Commission’s review, as it holds the authority to grant marketing authorizations for medicines within the EU.
In the QuANTUM-First trial, quizartinib was administered alongside standard cytarabine and anthracycline induction, followed by standard cytarabine consolidation, and then continued as maintenance monotherapy. This comprehensive approach demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone, with a notable median overall survival of 31.9 months for patients receiving quizartinib.
“Today’s positive CHMP opinion for quizartinib is an important step towards translating the clinical benefit observed in QuANTUM-First into an approved treatment option for patients in the EU with the difficult-totreat FLT3-ITD subtype of acute myeloid leukemia. If approved, quizartinib would be the first FLT3 inhibitor approved specifically for patients with newly diagnosed FLT3-ITD positive AML.”
– Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo
The safety profile of quizartinib in the trial aligned with previous clinical trials, with no new safety concerns identified. The most common grade 3 or 4 treatment-related adverse events included febrile neutropenia, hypokalemia, neutropenia, and pneumonia. Additionally, QTcF > 500 ms occurred in a small percentage of patients receiving quizartinib, and ventricular arrhythmia events with quizartinib were infrequent.
This positive recommendation for quizartinib signifies a potential advancement in the treatment options available for patients with newly diagnosed FLT3-ITD positive AML within the EU, offering hope for improved outcomes and enhanced therapeutic strategies.