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On August 4, 2020, the U.S. Food and Drug Administration (FDA) granted BST-236 (aspacytarabine) Fast Track designation for the treatment of acute myeloid leukemia (AML) in older patients (≥ 75 years) and in adult patients with comorbidities that make them unsuitable for intensive induction chemotherapy. The decision was based on the encouraging safety and efficacy data of the completed phase I/IIa study (NCT02544438) and the ongoing phase IIb study (NCT03435848).1
Cytarabine has been used as the backbone of AML therapy for over 40 years due to its superior efficacy. However, it is associated with toxicities that significantly limit its use, especially in older and medically compromised patients, therefore, there is a significant unmet need to improve outcomes in these patient groups.
BST-236 (aspacytarabine) consists of cytarabine covalently bound to asparagine and acts as a pro-drug of cytarabine, thereby enabling high-dose therapy with lower systemic exposure to free cytarabine, which may help to reduce the toxicities normally associated with cytarabine1. BST-236 has been previously granted orphan drug designation by the FDA.
Primary outcome: Complete remission
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