Pharmacy Prior Authorization Criteria

Vanflyta (quizartinib)

For diagnosis of Acute Myeloid Leukemia
Indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.
Limitations of Use: Vanflyta is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with Vanflyta in this setting has not been demonstrated.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

Patient has a FMS-like tyrosine kinase 3 (FLT3) internal tandem duplication (FLT3-ITD) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test (e.g., LeukoStrat CDx FLT3 Mutation Assay) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

AND

Used in combination with standard cytarabine and anthracycline (e.g., daunorubicin, idarubicin) induction and cytarabine consolidation
Used as maintenance monotherapy following consolidation chemotherapy

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

2024-09-04, 2023-08-30

Vanflyta Prescribing Information. Daiichi Sankyo, Inc., Basking Ridge. June 2024.
clinicaltrials.gov. Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) (QuANTUM-First). Available at: https://clinicaltrials.gov/study/NCT02668653?term=nct02668653&rank=1. Accessed August 29, 2023.