According to a press release yesterday from Daiichi Sankyo Pharmaceutical Co., Ltd., VANFLYTA (quizartinib) has been launched in the United States. This drug is the first and currently only FLT3 inhibitor approved by the FDA, specifically for all three stages of treatment for FLT3-ITD-positive acute myeloid leukemia (AML) – induction, consolidation, and maintenance in non-transplant patients.
In Japan, VANFLYTA was first approved in 2019 as a monotherapy for the treatment of adult patients with relapsed/refractory FLT3-ITD-mutant AML. This makes it the first and only FLT3 inhibitor approved in Japan for the treatment of newly diagnosed AML.
VANFLYTA was approved by the FDA on July 20, 2023, for use in combination with standard cytarabine and anthracycline antibiotics for induction and consolidation therapy, and as maintenance monotherapy after consolidation chemotherapy, for the treatment of newly diagnosed adult patients with FLT3-ITD-positive AML as indicated by an FDA-approved test. VANFLYTA is not indicated for maintenance monotherapy after allogeneic hematopoietic stem cell transplantation (HSCT); in this case, whether VANFLYTA improves overall survival has not been demonstrated.
This approval is based on the results of the Quantum-First trial, in which, compared with standard chemotherapy alone, VANFLYTA in combination with standard cytarabine and anthracyclines for induction therapy, standard cytarabine for consolidation therapy, and continued maintenance monotherapy after consolidation therapy in newly diagnosed FLT3-ITD-positive AML patients reduced the risk of death by 22%.
In patients receiving VANFLYTA, the most common adverse reactions observed included lymphopenia, hypokalemia, hypoalbuminemia, hypophosphatemia, elevated alkaline phosphatase, hypomagnesemia, febrile neutropenia, diarrhea, mucositis, nausea, and hypocalcemia.
Patient selection for treatment should be based on the presence or absence of FLT3-ITD mutations. LeukoStrat CDx FLT3 mutation testing has been approved as an adjunct diagnostic tool for VANFLYTA.
