CPX-351 (Vyxeos®, daunorubicin and cytarabine liposome for injection) is a dual-drug liposomal encapsulation of daunorubicin and cytarabine first approved by the U.S. Food and Drug Administration on August 3 2017 and by the European Commision in August 2018.
Vyxeos® is the first approved treatment (an innovative reformulation of two chemotherapies) for adult patients with certain types of high-risk acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). More recently in March 2021, the FDA revised the label to include pediatric patients aged 1 year and older.
Clinical data that supported the first approval application was published in J Clin Oncol.
The Leukemia & Lymphoma Society's Therapy Acceleration Program® (TAP) committed more than $9 million in a partnership with Celator Pharmaceuticals between 2009-2016 to advance the new therapy through both Phase 2 and Phase 3 clinical development. The clinical study that led to approval by the FDA was supported in part by LLS TAP. Celator was acquired by Jazz Pharmaceuticals in 2016.