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Patients were stratified for age (60 to 69 and 70 to 75 years of age) and AML type; treatment-related AML, AML with documented history of myelodysplastic syndrome (MDS) with prior treatment with hypomethylating agent therapy, AML with documented history of MDS without prior hypomethlyating agent therapy, AML with a documented history of chronic myelomonocytic leukemia (CMMo L), and de novo AML with a karyotype characteristic of MDS.Patients were randomized 1:1 to receive either VYXEOS or 7 3.Event-free survival was also statistically significant in favor of VYXEOS. The median event-free survival was 2.53 months in the VYXEOS arm compared to 1.31 months in the 7 3 arm."We believe the promising primary efficacy results of CPX-351 in high risk AML, across multiple parameters, support its use as the new standard of care in a difficult-to-treat population," said Jeffrey E. D., senior member and chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center and the principal investigator for the study.Grade 3-5 non-hematologic and hematologic adverse events were similar between the VYXEOS and 7 3 arms.
The Phase 3 trial compared to the standard of care regimen of cytarabine and daunorubicin known as 7 3."We are very pleased to have this opportunity to share the data from our Phase 3 trial with the oncology community.This successful outcome represents an important advance for AML patients, their families and clinicians," said , Chief Executive Officer of Celator Pharmaceuticals.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.
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About VYXEOS 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 ration.