The phase 3 trial of Celator Pharmaceuticals' Vyxeos (CPX-351) in patients with high-risk acute myeloid leukemia (AML) demonstrated statistically significant improvement in overall survival.
In the phase 3 study of 309 patients with secondary, or high risk, acute myeloid leukemia, those who received Vyxeos on average lived for 9.56 months after the start of the trial, compared with 5.95 months for those who got the standard combination treatment of cytarabine and daunorubicin.
Two years after the start of the study, 31.1% in the Vyxeos group were still alive, compared to 12.3% for the standard treatment group.
Celator plans to submit a new drug application (NDA) for Vyxeos with the US Food and Drug Administration (FDA) later this year.
The company also expects to submit a marketing authorization application with the European Medicines Agency in the first quarter of 2017.
Celator Pharmaceuticals CEO Scott Jackson said: "The successful outcome of this Phase 3 trial represents an important advance for AML patients, their families and clinicians.
"It also marks a major milestone for Celator, for Vyxeos, and for our CombiPlex platform."
Vyxeos Liposome for Injection is a nano-scale co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ration.
Celator said it represents a novel approach in the development of 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 and the European Commission granted orphan drug status to Vyxeos to treat AML.