Daiichi Sankyo’s Vanflyta (quizartinib) has been approved in the European Union (EU) for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by Vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.
Vanflyta is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.
The authorization by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the QUANTUM-First trial, which were published in The Lancet. In QuANTUM-First, Vanflyta combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation, and continued as maintenance monotherapy following consolidation, demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.78 [95% CI: 0.62-0.98; p=0.032]) in patients with newly diagnosed FLT3-ITD positive AML. Median overall survival was 31.9 months for patients receiving Vanflyta (n=268; 95% CI: 21.0-NE) compared to 15.1 months for patients in the control arm (n=271; 95% CI: 13.2-26.2) at a median follow-up of 39.2 months.
“This approval of Vanflyta represents an important advancement for frontline treatment of patients with FLT3-ITD positive acute myeloid leukaemia, an aggressive and historically difficult-to-treat subtype,” said Richard F. Schlenk, MD, Professor and Head of the Trial Center of the National Center of Tumour Diseases, Heidelberg University Hospital and German Cancer Research Center, Germany. “Vanflyta is a potent and selective FLT3 inhibitor that significantly improved overall survival when added to standard chemotherapy and it will be a valuable treatment option for newly diagnosed FLT3-ITD positive AML.”
“This approval of Vanflyta is very welcome news for eligible patients diagnosed with FLT3-ITD positive AML each year,” said Samantha Nier, network director, Acute Leukaemia Advocates Network (ALAN). “New medicines and treatment approaches are needed to help patients with this difficult type of leukaemia live longer, and we look forward to Vanflyta becoming available in countries throughout the EU.”
The safety profile of Vanflyta in QuANTUM-First was consistent with previous clinical trials with no new safety signals observed. The most common grade 3 or 4 treatment emergent adverse events (occurring in = 10% of patients) were febrile neutropenia (43%), hypokalaemia (19%), neutropenia (18%) and pneumonia (11%). QTcF > 500 ms occurred in 2.3% of patients receiving Vanflyta and 0.8% of patients discontinued Vanflyta due to QT prolongation. Ventricular arrhythmia events with Vanflyta were uncommon. Two (0.8%) patients receiving Vanflyta experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalaemia.
“With the approval of Vanflyta in the European Union, patients diagnosed with FLT3-ITD positive acute myeloid leukaemia may for the first time receive a targeted therapy developed and approved specifically for their disease subtype,” said Ken Keller, global head of oncology business, and president and CEO, Daiichi Sankyo, Inc. “Vanflyta is the second innovative medicine from our oncology pipeline approved in the EU and its successful development reflects our commitment to creating new standards of care for patients with cancer.”
QuANTUM-First is a randomized, double-blind, placebo-controlled, global phase 3 study evaluating Vanflyta in combination with standard induction and consolidation therapy, including hematopoietic stem cell transplant (HSCT), and as maintenance monotherapy, in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive AML. Patients were randomized 1:1 to receive Vanflyta or placebo combined with cytarabine and anthracycline induction and cytarabine consolidation chemotherapy followed by up to three years of treatment with single-agent maintenance.
The primary study endpoint was overall survival. Secondary endpoints include event-free survival, postinduction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD measurable residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints including duration of CR also were evaluated.
QuANTUM-First enrolled 539 patients at 193 study sites in 26 countries across Asia, Europe, North America, Oceania and South America.
More than 474,500 new cases of leukaemia were reported globally in 2020 with more than 311,500 deaths.
AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults.
In Europe, approximately 18,000 people are diagnosed with AML each year and the five-year survival rate is reported at
17% for adult patients.6,7
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