VANFLYTA (quizartinib), FDA Approved in the U.S. for Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia, Available at Biologics by McKesson

August 04, 2023

CARY, N.C., Aug. 4, 2023 Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare diseases, was selected by Daiichi Sankyo, Inc., as a specialty pharmacy provider for VANFLYTA® (quizartinib). VANFLYTA is indicated for use 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.

VANFLYTA, approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. on July 20, 2023, is an orally administered therapy. AML is one of the most common forms of leukemia in adults. Up to 37% of newly diagnosed patients with AML have a FLT3 gene mutation, and approximately 80% of these are FLT3-ITD mutations, which drive cancer growth and contribute to increased risk of relapse and shorter overall survival. The five-year survival rate for patients with FLT3-ITD AML has been reported at approximately 20%. The most common adverse reactions in 265 patients who received VANFLYTA in the QuANTUM-First trial were neutropenia (25.0%), thrombocytopenia (22.7%), nausea (20.6%), and electrocardiogram QT prolonged (19.3%). The safety profile of VANFLTYA in QuANTUM-First was consistent with previous use, and no new safety concerns were identified.

“Biologics by McKesson is honored to work with Daiichi Sankyo, Inc. to offer VANFLYTA to help meet the unmet needs of the FLT3-ITD AML community,” said Daniel Weaver, director of Clinical Innovation and Strategy for Biologics by McKesson. “Due to certain risks, VANFLYTA is only available through a Risk Evaluation and Mitigation Strategy (REMS) program. As a leading provider of risk assessment and care planning, Biologics is proud to help ensure that patients taking VANFLYTA get the level of care they need and deserve.”

Biologics by McKesson is committed to and recognized for its level of customer service as well as its innovative, high-touch approach. Putting patients first in all they do, each team includes pharmacists with in-depth knowledge of therapies, experienced nurses, and financial counselors who are familiar with various financial assistance programs and organizations that help patients.

For more information about the symptoms, diagnosis, and treatment of AML, please click here. For more information about VANFLYTA, including full prescribing information, please click here.

VANFLYTA™ is a trademark of Daiichi Sankyo Company.

About Biologics by McKesson

Biologics by McKesson is an independent specialty pharmacy with more than 29 years of experience connecting patients to life-changing medications in oncology and other rare and complex therapeutic areas. Built on the foundation of deep clinical expertise and a high-touch approach to patient care, Biologics delivers seamless access and personalized engagement, so patients get the most out of the care they receive. As a business within McKesson Corporation, Biologics harnesses unparalleled reach and connectivity across the healthcare system to connect the dots between payers, providers, and biopharma, so together, they can deliver better care and outcomes for every patient.

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