CPX-351 was approved by the Food and Drug Administration (FDA) in 2017 as an induction chemotherapy regimen for patients with AML-MRC or t-AML as defined by 2016 World Health Organization (WHO) classification. A large randomized phase 3 study that led to approval of CPX-351 included only ...
Lin3, Kobby Asubonteng4, Stefan Faderl5, Jeffrey E. Lancet6 and Thomas Prebet7 Abstract CPX-351 (Europe: Vyxeos® liposomal; United States: Vyxeos®) is a dual-drug liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio. ...
Study Design of an Expanded Access Protocol of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Patients 60-75 Years of Age with Secondary Acute Myeloid Leukemia A randomized trial comparing idarubicin plus cytarabine (IDA/Ara-C) with doxorubicin plus cytarabine (ADM/Ara-C) in induction ther...
Study Design of an Expanded Access Protocol of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Patients 60-75 Years of Age with Secondary Acute Myeloid LeukemiaA randomized trial comparing idarubicin plus cytarabine (IDA/Ara-C) with doxorubicin plus cytarabine (ADM/Ara-C) in induction ...
Response to induction treatment, evaluated per protocol between day 28 and day 42, often had to be delayed due to prolonged cytopenia. For response evaluation, ELN 2017 criteria for AML were used in addition to IWG 2006 criteria for MDS, as the latter often proved difficult to interpret in ...
Liposomal daunorubicin and cytarabine (CPX-351) was recently FDA approved for the treatment of sAML, based on a randomized phase III trial that found a higher complete remission (CR) rate, event-free survival (EFS), and overall survival (OS) with CPX-351 compared to 7+3 chemotherapy (...