Dr. Erba on the FDA Approval of CPX-351 in AML

Harry Erba, MD, PhD
Published Online: Friday, Aug 11, 2017



Harry Erba, MD, PhD, professor of medicine, director, University of Alabama (UAB) Hematologic Malignancy Program, UAB School of Medicine, sheds light on the FDA approval of CPX-351 (Vyxeos) in acute myeloid leukemia (AML).

One of the challenges in treatment of patients with AML is based on the biology of the disease. Many patients have AML that rose from myelodysplastic syndrome, a myeloproliferative neoplasm, or even induced by prior chemotherapy. For these patients, they are often more resistant to chemotherapy and their long-term outcomes are worse. These disease states are also more common in older patients. Therefore, developing novel therapeutic options for these populations is needed.

The FDA recently approved CPX-351, which is a fixed-combination of daunorubicin and cytarabine, for adult patients with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes, based on an improvement in overall survival in a phase III study.


Harry Erba, MD, PhD, professor of medicine, director, University of Alabama (UAB) Hematologic Malignancy Program, UAB School of Medicine, sheds light on the FDA approval of CPX-351 (Vyxeos) in acute myeloid leukemia (AML).

One of the challenges in treatment of patients with AML is based on the biology of the disease. Many patients have AML that rose from myelodysplastic syndrome, a myeloproliferative neoplasm, or even induced by prior chemotherapy. For these patients, they are often more resistant to chemotherapy and their long-term outcomes are worse. These disease states are also more common in older patients. Therefore, developing novel therapeutic options for these populations is needed.

The FDA recently approved CPX-351, which is a fixed-combination of daunorubicin and cytarabine, for adult patients with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes, based on an improvement in overall survival in a phase III study.



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