FOR IMMEDIATE RELEASE:
VANFLYTA® (quizartinib) Now Available from Onco360 and Indicated in Combination with Standard Cytarabine and Anthracycline Induction and Cytarabine Consolidation, and as the 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.
Louisville, KY — July 24, 2023 — Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected by Daiichi Sankyo to be a specialty pharmacy partner for VANFLYTA® (quizartinib). VANFLYTA is a kinase inhibitor 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. VANFLYTA is not indicated as a maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.
“Onco360 is grateful for the opportunity to partner with the team at Daiichi Sankyo and become a specialty pharmacy provider for VANFLYTA patients,” said Benito Fernandez, Chief Commercial Officer. “We are committed to providing a world class experience for patients and their caregivers through our team of experienced board-certified oncology pharmacists and oncology-certified nurses who are experts in supporting the highly specialized needs of certain patients battling acute myeloid leukemia across the United States.”
AML is one of the most common forms of leukemia in adults, according to the American Cancer Society, and an estimated 20,380 new cases will be diagnosed in the U.S. in 2023. 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.1
VANFLYTA is manufactured by Daiichi Sankyo and is the third innovative medicine from their oncology pipeline approved by the FDA. It is the first and only FLT3 inhibitor to be approved by the FDA specifically for FLT3-ITD positive AML across the three phases of treatment – induction, consolidation, and maintenance in patients without transplant. This approval was based on results of the QuANTUM-First trial where VANFLYTA combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation, and continued as maintenance monotherapy following consolidation, resulted in a 22% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.78 [95% CI: 0.62-0.98; 2-sided p=.0324]) in patients with newly diagnosed FLT3-ITD positive AML.
For full prescribing information, please visit: VANFLYTA Prescribing Information
- VANFLYTA® First FLT3 Inhibitor Approved in the U.S. Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML. July 20, 2023. Accessed July 24, 2023. https://www.businesswire.com/news/home/20230720059692/en/VANFLYTA%C2%AE-First-FLT3-Inhibitor-Approved-in-the-U.S.-Specifically-for-Patients-with-Newly-Diagnosed-FLT3-ITD-Positive-AML
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