08/09/2023

Now Available: VANFLYTA (quizartinib)

July 20, 2023, the US Food and Drug Administration (FDA) approved  VANFLYTA (quizartinib)

VANFLYTA® (quizartinib) 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-ITD positive as detected by an FDA-approved test. 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.¹]

VANFLYTA is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS because of the serious risk of QT prolongation, torsades de pointes, and cardiac arrest. Prescribers and pharmacies can enroll today in the VANFLYTA REMS at www.VANFLYTAREMS.com.

VANFLYTA has Boxed WARNINGS for QT prolongation, torsades de pointes, and cardiac arrest. Please see Important Safety Information below and click here for full Prescribing Information, including Boxed WARNINGS, and click here for Medication Guide.

Patient Support Programs

Provider and patient support—including financial assistance programs and information on distribution and access—is provided through Daiichi Sankyo Access Central (www.dsiaccesscentral.com/hcp/vanflyta).  For both general questions and patient-specific situations, you may contact me directly or speak with an Access Central Coordinator at 1-866-437-4669.  [Additionally, please see the following enclosed attachments:

• Patient Enrollment Form: allows for enrollment into Daiichi Sankyo Access Central support programs for appropriate patients prescribed VANFLYTA
• Access & Support Services Brochure: details VANFLYTA patient support programs and distribution model
• Prior Authorization Checklist: includes considerations for submitting a PA request for appropriate patients prescribed VANFLYTA
• Sample Letter of Medical Necessity: templated letter that can be used as a resource when writing letters to insurers for appropriate patients prescribed VANFLYTA
• Resource Guide: provides overview of key VANFLYTA websites and contact information]

VANFLYTA Package Information

VANFLYTA is available via network specialty pharmacies and specialty distributors.  A list is available at www.VanflytaHCP.com

Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

Catherine Dillon
Associate Director, Field Reimbursement
DE, NJ, MD, PA
Prior Authorization Certified Specialist (PACS)
Daiichi Sankyo Oncology
Cell 484-459-4308
cdillon@dsi.com