The FDA has approved the drug Mylotarg as a combination and stand-alone therapy for CD33-positive acute myeloid leukemia after it showed safety and efficacy in a series of clinical trials. Photo by toeytoey/Shutterstock
Sept. 5 (UPI) -- The U.S. Food and Drug Administration has announced it approved Mylotarg, or gemtuzumab, for the treatment of adults with newly diagnosed acute myloid leukemia, or AML.
AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of white blood cells in the bloodstream. Approximately 21,380 people will be diagnosed with AML this year and that 10,590 patients with AML will die of the disease, according to The National Cancer Institute of the National Institutes of Health.
The FDA approved Mylotarg to treat adult patients with newly diagnosed AML whose tumors express the CD33 antigen, or CD33-positive AML. The agency also approved Mylotarg fro the treatment of patients age 2 and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment.
"We are approving Mylotarg after a careful review of the new dosing regimen, which has shown that the benefits of this treatment outweigh the risk," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a press release.
"Mylotarg's history underscores the importance of examining alternative dosing, scheduling, and administration of therapies for patients with cancer, especially in those who may be most vulnerable to the side effects of treatment."
Mylotarg, in combination with chemotherapy for adults, was tested in clinical trials of 271 patients with newly diagnosed CD33-positive AML who received Mylotarg in combination with daunorubicin and cytarabine or daunorubicin and cytarabine without Mylotarg.
The trial showed that patients who received Mylotarg in combination with chemotherapy had a longer duration without complications compared to those who received chemotherapy alone.
Two other clinical trials of Mylotarg as a stand-alone treatment also included 237 patients with newly diagnosed AML who did not receive intensive chemotherapy. The trial showed that patients who received Mylotarg survived longer than those who received only best supportive care.
The second trial of 57 patients with CD33-positive AML who had one relapse of the disease showed patients who received a single course of Mylotarg led to 26 percent achieving complete remission lasting a median of 11.6 months.