FDA Fast-Tracks Acute Myeloid Leukemia Treatment

The U.S. Food and Drug Administration has fast-tracked Celator Pharmaceuticals' experimental treatment for secondary acute myeloid leukemia (AML) in elderly patients.

Fast Track Designation from the FDA makes it more likely that, should the therapy perform well in later phase clinical trials, it will be made available to patients more quickly.

Treatment suggests it will be highly effective treating elderly patients

The treatment is currently known as CPX-351. It is a special combination of two standard chemotherapy drugs: a liposomal formulation of cytarabine and daunorubicin. Early stage clinical trials of CPX-351 suggest that it is highly effective in treating elderly patients with secondary acute myeloid leukemia (AML), a high-risk type of AML with a very poor prognosis and a disease for which the standard of care has not changed or improved in over three decades.

CPX-351 has been tested in clinical trials against standard delivery of the same two drugs (cytarabine and daunorubicin) in these patients and demonstrated higher efficacy and less toxicity. Notably, CPX-351 doubled the number of patients who achieved complete remission, and practically tripled the number of patients who survived a year following treatment.

Source: LLS