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Karen L Smith

Karen L Smith

Jazz Pharmaceuticals, USA

Title: Liposomal encapsulation for improved drug delivery and patient outcomes

Biography

Biography: Karen L Smith

Abstract

Vyxeos (cytarabine:daunorubicin) liposome for injection, also known as CPX-351, is a nano-scale co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio. Vyxeos represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nano-scale liposome in order to maintain the desired ratio following administration. The FDA granted Breakthrough Therapy designation to Vyxeos for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos was granted orphan drug status for the treatment of AML by the FDA and the European Commission. Vyxeos was also granted Fast Track designation for the treatment of elderly patients with secondary AML by the FDA. Taking two cytotoxic agents that are currently standard of care (known as 7+3) and encapsulating into a liposomal formulation produced statistically significant results with a 3.6 month improvement in favor of Vyxeos. The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3. This review will focus on the potential for drug liposomal encapsulation and utilizing this approach for better patient outcomes.