Additional Relevant Details The Breakthrough Therapy Designation is supported by data from untreated patients, 65 years or older with AML and reported in one investigational study. AML is typically treated with chemotherapy and the intensity of chemotherapy depends on a person's age and health. However, no single standard of care exists for older patients with AML, as there are no FDA- approved therapies for patients not eligible to receive standard induction therapy/intensive chemotherapy. Because induction-therapy-related mortality for patients 55 years of age or older has been estimated at 15 to 20 percent, these patients are best managed with non-intensive approaches.